Product Code: JWY
FDA class 2
21 CFR 866.1640
Manual Antimicrobial Susceptibility Test Systems
Microbiology
Manual Antimicrobial Susceptibility Test Systems are manually performed laboratory systems used to determine the susceptibility or resistance of bacterial isolates to antimicrobial agents, providing minimum inhibitory concentration (MIC) values or interpretive susceptibility categories to guide therapeutic decisions. It is classified as FDA Class 2, indicating moderate risk and requiring 510(k) premarket notification. The product code is JWY, regulated under 21 CFR 866.1640, and falls within the Microbiology medical specialty. This device is eligible for third-party review.
510(k)s
441
FEI Numbers
9
Registration Numbers
9
Unique Applicants
48
Years Active
45
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Basic Information
- Product Code
- JWY
- Device Class
- FDA class 2
- Regulation Number
- 866.1640
- Medical Specialty
- Microbiology
- Review Panel
- MI
- Submission Type
- 1
Device Characteristics
✗
GMP Exempt
✗
Implant
✗
Life Sustain/Support
✓
Third Party
—
Summary Malfunction Reporting
510(k) Clearance History
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Related 510(k) Clearances
This FDA classification is associated with 441 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K260447 | ETEST Gepotidacin (GEP) (0.016-256 µg/mL) | Apr 21, 2026 | Substantially Equivalent | bioMérieux SA |
| K260696 | MTS Gepotidacin 0.016-256 µg/mL | Apr 17, 2026 | Substantially Equivalent | Liofilchem s.r.l. |
| K252114 | MTS Aztreonam-Avibactam 0.016/4 - 256/4 µg/mL | Oct 02, 2025 | Substantially Equivalent | Liofilchem s.r.l. |
| K252062 | The Sensititre 18-24 hour MIC or Breakpoint Susceptibility System with Colistin in the dilution range of 0.12-16 ug/mL | Sep 25, 2025 | Substantially Equivalent | Thermo Fisher Scientific |
| K250575 | The Sensititre 18 - 24 hour MIC or Breakpoint Susceptibility System with Aztreonam/avibactam in the dilution range of 0.008/4 - 64/4 ug/mL | Sep 05, 2025 | Substantially Equivalent | Thermo Fisher Scientific |
| K252014 | The Sensititre 18-24 hour MIC or Breakpoint Susceptibility System with Amikacin in the dilution range of 0.25-256 ug/mL | Aug 28, 2025 | Substantially Equivalent | Thermo Fisher Scientific |
| K251580 | MTS Sulbactam-Durlobactam 0.004/4 - 64/4 µg/mL (SUD) | Aug 20, 2025 | Substantially Equivalent | Liofilchem s.r.l. |
| K250990 | The Sensititre 18-24 hour MIC or Breakpoint Susceptibility System with Ciprofloxacin in the dilution range of 0.002-64 ug/mL | Jun 30, 2025 | Substantially Equivalent | Thermo Fisher Scientific |
| K242843 | The Sensititre 20-24 hour Haemophilus influenzae/Streptococcus pneumoniae (HP) MIC or Breakpoint Susceptibility System with Ceftobiprole in the dilution range of 0.008-16 ug/mL. | Jun 20, 2025 | Substantially Equivalent | Thermo Fisher Scientific |
| K250856 | ETEST Aztreonam/Avibactam (AZA) (0.016/4-256/4 µg/mL) | Jun 12, 2025 | Substantially Equivalent | Biomérieux |
| K242659 | The Sensititre 18-24 hour MIC or Breakpoint Susceptibility System with Vancomycin in the dilution range of 0.25-128 ug/mL | May 22, 2025 | Substantially Equivalent | Thermo Fisher Scientific |
| K250274 | ETEST Imipenem/Relebactam P. aeruginosa (IRPA) (0.008/4-128/4 µg/mL) | Apr 30, 2025 | Substantially Equivalent | Biomerieux S.A. |
| K242658 | The Sensititre 18-24 hour MIC or Breakpoint Susceptibility System with Moxifloxacin in the dilution range of 0.008-16 ug/mL | Apr 15, 2025 | Substantially Equivalent | Thermo Fisher Scientific |
| K243201 | The Sensititre 20-24 hour Haemophilus influenzae/Streptococcus pneumoniae (HP) MIC or Breakpoint Susceptibility System with penicillin in the dilution range of 0.015-32 ug/mL | Feb 10, 2025 | Substantially Equivalent | Thermo Fisher Scientific |
| K242905 | The Sensititre 20-24 hour Haemophilus influenzae/Streptococcus pneumoniae (HP) MIC or Breakpoint Susceptibility System with Linezolid in the dilution range of 0.12-32 ug/mL | Feb 10, 2025 | Substantially Equivalent | Thermo Fisher Scientific |
| K243202 | MTS Ceftobiprole 0.002-32 µg/mL | Jan 30, 2025 | Substantially Equivalent | Liofilchem s.r.l. |
| K243169 | The Sensititre 18-24 hour MIC or Breakpoint Susceptibility System with Ceftobiprole in the dilution range of 0.008-16 ug/mL | Dec 19, 2024 | Substantially Equivalent | Thermo Fisher Scientific |
| K242653 | The Sensititre 18-24 hour MIC or Breakpoint Susceptibility System with Linezolid in the dilution range of 0.25-32 ug/mL | Dec 05, 2024 | Substantially Equivalent | Thermo Fisher Scientific |
| K242657 | The Sensititre 18-24 hour MIC or Breakpoint Susceptibility System with Daptomycin in the dilution range of 0.03-64 ug/mL | Nov 26, 2024 | Substantially Equivalent | Thermo Fisher Scientific |
| K242021 | The Sensititre 20 - 24 hour Haemophilus influenzae/Streptococcus pneumoniae (HP) MIC or Breakpoint Susceptibility System with Meropenem in the dilution range of 0.015 - 32 ug/ml. | Oct 09, 2024 | Substantially Equivalent | Thermo Fisher Scientific |
| K241967 | The Sensititre 20 - 24 hour Haemophilus influenzae/Streptococcus pneumoniae (HP) MIC or Breakpoint Susceptibility System with ceftriaxone in the dilution range of 0.015 - 2 ug/ml. | Oct 01, 2024 | Substantially Equivalent | Thermo Fisher Scientific |
| K240445 | The Sensititre 20 - 24 hour Haemophilus influenzae/Streptococcus pneumoniae (HP) MIC or Breakpoint Susceptibility System with Imipenem in the dilution range of 0.015 - 4 ug/ml. | May 16, 2024 | Substantially Equivalent | Thermo Fisher Scientific |
| K232310 | Sensititre 20-24 hour Haemophilus influenzaelStreptococcus pneumoniae MIC or Breakpoint Susceptibility System with Ceftolozane-tazobactam in the dilution range of 0.03/4-64/4ug/ml | Oct 31, 2023 | Substantially Equivalent | Thermo Fisher Scientific |
| K232395 | ETEST® Sulbactam/Durlobactam (SUD) (0.004/4-64/4 µg/mL), ETEST® SUD | Oct 05, 2023 | Substantially Equivalent | Biomérieux |
| K231988 | Sensititre 20-24-hour Haemophilus influenzae/Streptococcus pneumoniae MIC or Breakpoint Susceptibility System with Dalbavancin in the dilution range of 0.0005-2µg/ml | Aug 30, 2023 | Substantially Equivalent | Thermo Fisher Scientific |
| K231994 | Sensititre 18-24 hour MIC or Breakpoint Susceptibility System with Sulbactam-durlobactam in the dilution range of 0.015/4-32/4 ug/mL | Aug 25, 2023 | Substantially Equivalent | Thermo Fisher Scientific |
| K230935 | Sensititre 20-24 hour Haemophilus influenzae/Streptococcus pneumoniae MIC, or Breakpoint Susceptibility System with Imipenem-relebactam in the dilution, range of 0.03/4-128-4ug/ml (Haemophilus influenzae) | Jun 30, 2023 | Substantially Equivalent | Thermo Fisher Scientific |
| K230479 | ComASP Cefiderocol 0.008-128 | May 18, 2023 | Substantially Equivalent | Liofilchem s.r.l. |
| K223844 | Sensititre 20-24-hour Haemophilus influenzae/Streptococcus pneumoniae MIC or Breakpoint Susceptibility System with Delafloxacin in the dilution range of 0.00025-8ug/ml (Streptococcus species) and 0.000125-8ug/ml (Haemophilus influenzae) | Mar 21, 2023 | Substantially Equivalent | Thermo Fisher Scientific |
| K203741 | Sensititre 18-24 hour MIC or Breakpoint Susceptibility System with Cefiderocol in the dilution range of 0.03-64 ug/ml | Dec 20, 2021 | Substantially Equivalent | Thermo Fisher Scientific |
| K210757 | ETEST Fosfomycin (FO) (0.032-512 µg/mL) | Nov 12, 2021 | Substantially Equivalent | Biomerieux S.A. |
| K211672 | MTS Piperacillin-tazobactam 0.016/4 - 256/4µg/mL | Oct 20, 2021 | Substantially Equivalent | Liofilchem s.r.l. |
| K202612 | Sensititre 20-24 hour Haemophilus influenzae /Streptococcus pneumoniae MIC or Breakpoint Susceptibility System with Dtest (containing erythromycin at 1 ug/mL and clindamycin at 0.5 ug/mL) | Jul 23, 2021 | Substantially Equivalent | Thermo Fisher Scientific |
| K202423 | MicroScan MICroSTREP plus Panels with Tetracycline (0.06-16 µg/mL) | May 18, 2021 | Substantially Equivalent | Beckman Coulter, Inc. |
| K200512 | ETEST Plazomicin (PLZ) (0.016-256 µg/mL) | May 07, 2020 | Substantially Equivalent | Biomérieux SA |
| K200308 | MTS Lefamulin 0.016- 256 µg/mL | Apr 06, 2020 | Substantially Equivalent | Liofilchem S. R. 1. |
| K200180 | MTS Omadacycline 0.002 - 32 ug/mL | Mar 20, 2020 | Substantially Equivalent | Liofilchem s.r.l. |
| K193538 | Sensititre 18-24 hour MIC or Breakpoint Susceptibility System with Cefiderocol in the dilution range of 0.03-64 µg/ml | Mar 12, 2020 | Substantially Equivalent | Thermo Fisher Scientific |
| K193024 | Sensititre 20-24 hour Haemophilus influenzae/Streptococcus pneumoniae MIC or Breakpoint, Susceptibility System with Lefamulin in the dilution range of 0.008-16ug/mL | Jan 08, 2020 | Substantially Equivalent | Thermo Fisher Scientific |
| K192738 | ETEST Delafloxacin (DFX) (0.002-32 µg/mL) | Nov 26, 2019 | Substantially Equivalent | Biomerieux S.A. |
| K192355 | MicroScan Dried Gram Negative MIC/Combo Panels with Meropenem (Mer) (0.004-32ug/mL) | Nov 14, 2019 | Substantially Equivalent | Beckman Coulter, Inc. |
| K192729 | Sensititre 18-24 Hour MIC or Breakpoint Susceptibility System with Lefamulin in the dilution range of 0.008-16ug/ml | Nov 06, 2019 | Substantially Equivalent | Thermo Fisher Scientific |
| K192345 | MTS Ampicillin-Sulbactam 0.016/0.008 - 256/128 µg/mL | Oct 31, 2019 | Substantially Equivalent | Liofilchem s.r.l. |
| K192250 | Sensititre 18-24 hour MIC or Breakpoint Susceptibility System with Imipenem-Relebactam in the dilution range of 0.03/4-256/4 ug/mL | Oct 16, 2019 | Substantially Equivalent | Thermo Fisher Scientific |
| K192050 | ETEST Eravacycline (ERV) (0.002 32 µg/mL) | Sep 27, 2019 | Substantially Equivalent | Biomerieux S.A. |
| K191908 | MTS Imipenem 0.016-256 µg/mL | Sep 04, 2019 | Substantially Equivalent | Liofilchem s.r.l. |
| K191809 | MTS Imipenem-relebactam 0.002/4-32/4 µg/mL | Aug 23, 2019 | Substantially Equivalent | Liofilchem s.r.l. |
| K191953 | ETEST Imipenem/Relebactam (IPR) (0.002/4-32/4 ug/mL) | Aug 22, 2019 | Substantially Equivalent | Biomerieux S.A. |
| K190914 | MTS Doxycycline 0.016 - 256 µg/mL | May 29, 2019 | Substantially Equivalent | Liofilchem s.r.l. |
| K190154 | ETEST Piperacillin/Tazobactam (P/T) (0.016/4-256/4 ug/mL) | May 01, 2019 | Substantially Equivalent | Biomerieux S.A. |
| K190109 | MicroScan Dried Gram Negative MIC/Combo Panels with Eravacycline (ERV) (0.016-32 ug/mL) | Apr 18, 2019 | Substantially Equivalent | Beckman Coulter, Inc. |
| K190252 | MTS Gentamicin 0.016 - 256 µg/mL | Mar 22, 2019 | Substantially Equivalent | Liofilchem s.r.l. |
| K183527 | MTS Ciprofloxacin 0.002 - 32 µg/mL | Mar 19, 2019 | Substantially Equivalent | Liofilchem s.r.l. |
| K183324 | Sensititre 20-24 hour Haemophilus influenzae/Streptococcus pneumoniae MIC or Breakpoint Susceptibility System with Omadacycline in the dilution range of 0.008 - 32 ug/mL | Feb 15, 2019 | Substantially Equivalent | Thermo Fisher Scientific |
| K183140 | MTS Tetracycline 0.016 - 256 ug/mL | Jan 11, 2019 | Substantially Equivalent | Liofilchem s.r.l. |
| K183031 | ETEST Meropenem/Vaborbactam (MEV) (0.004/8-64/8 µg/mL) | Jan 11, 2019 | Substantially Equivalent | Biomerieux S.A. |
| K183033 | Sensititre 18-24 hour MIC or Breakpoint Susceptibility System with Omadacycline in the dilution range of 0.03-32ug/ml | Jan 04, 2019 | Substantially Equivalent | Thermo Fisher Scientific |
| K183115 | MTS Levofloxacin 0.002 - 32 µg/mL | Dec 20, 2018 | Substantially Equivalent | Liofilchem s.r.l. |
| K182922 | MTS Omadacycline 0.002-32 µg/mL | Dec 14, 2018 | Substantially Equivalent | Liofilchem s.r.l. |
| K182797 | Sensititre 18-24 hour MIC or Breakpoint Susceptibility System with Eravacycline in the dilution range of 0.008- 16 µg/mL | Nov 30, 2018 | Substantially Equivalent | Thermo Fisher Scientific |
| K182557 | MTS Eravacycline 0.002 - 32 µg/mL | Nov 02, 2018 | Substantially Equivalent | Liofilchem s.r.l. |
| K181889 | MTS Penicillin 0.002- 32 µg/mL | Sep 13, 2018 | Substantially Equivalent | Liofilchem s.r.l. |
| K181946 | Sensititre 18-24 hour MIC Breakpoint Susceptibility System with Plazomicin in the dilution range of 0.06-128 ug/mL | Aug 08, 2018 | Substantially Equivalent | Thermo Fisher Scientific |
| K181708 | MTS Plazomicin 0.016-256 µg/mL | Jul 31, 2018 | Substantially Equivalent | Liofilchem s.r.l. |
| K180936 | ETEST Telavancin (TLA) (0.002-32 ug/mL) | Jul 03, 2018 | Substantially Equivalent | Biomerieux S.A. |
| K180886 | Liofilchem MIC Test Strip (MTS), Delafloxacin 0.002 - 32 ug/mL | May 18, 2018 | Substantially Equivalent | Liofilchem s.r.l. |
| K180339 | Liofilchem MIC Test Strip (MTS), Azithromycin 0.016 - 256 µg/mL | Apr 04, 2018 | Substantially Equivalent | Liofilchem s.r.l. |
| K180330 | Liofilchem MIC Test Strip (MTS)- Linezolid 0.016 - 256ug/mL | Mar 15, 2018 | Substantially Equivalent | Liofilchem s.r.l. |
| K173817 | Liofilchem MIC Test Strip (MTS), Ceftazidime-avibactam 0.016/4 - 256/4 µg/mL | Feb 28, 2018 | Substantially Equivalent | Liofilchem s.r.l. |
| K173307 | Liofilchem MIC Test Strip (MTS), Meropenem/vaborbactam 0.016/8 - 256/8 µg/mL | Dec 19, 2017 | Substantially Equivalent | Liofilchem s.r.l. |
| K173209 | Sensititre 18-24 hour MIC or Breakpoint Susceptibility System with Meropenem/Vaborbactam in the Dilution Range of 0.008/8 - 18/8 ug/mL | Dec 01, 2017 | Substantially Equivalent | Thermo Fisher Scientific |
| K172542 | Liofilchem MIC Test Strip (MTS)- Tedizolid 0.002 - 32 mg/mL. | Oct 23, 2017 | Substantially Equivalent | Liofilchem s.r.l. |
| K172454 | Sensititre 18-24 hour MIC or Breakpoint Susceptibility System with Delafloxacin in the dilution range of 0.004-8 ug/mL | Oct 13, 2017 | Substantially Equivalent | Thermo Fisher Scientific |
| K172109 | Liofilchem MIC Test Strip (MTS), Erythromycin 0.016 - 256 µg/mL | Sep 27, 2017 | Substantially Equivalent | Liofilchem s.r.l. |
| K172150 | Etest Ceftazidime/Avibactam (CZA) (0.016 - 256 ug/mL) | Sep 15, 2017 | Substantially Equivalent | bioMerieux, Inc. |
| K172274 | The Sensititre 20-24 hour Haemophilus influenzae/Streptococcus pneumoniae MIC or Breakpoint Susceptibility System with Delafloxacin in the dilution range of 0.00025-8µg/mL | Aug 30, 2017 | Substantially Equivalent | Thermo Fisher Scientific |
| K171906 | Liofilchem MIC Test Strip (MTS)- Delafloxacin 0.002 - 32 µg/mL | Aug 01, 2017 | Substantially Equivalent | Liofilchem s.r.l. |
| K171870 | The Sensititre 18-24 hour MIC or Breakpoint Susceptibility System with Delafloxacin in the dilution range of 0.0005 8 ug/mL | Aug 01, 2017 | Substantially Equivalent | Thermo Fisher Scientific |
| K170772 | Liofilchem MIC Test Strip (MTS)- Clindamycin 0.016 - 256 µg/mL | Jun 07, 2017 | Substantially Equivalent | Liofilchem s.r.l. |
| K170670 | Etest Ceftolozane/ Tazobactam (0.016-256 ug/ml) | May 31, 2017 | Substantially Equivalent | bioMerieux, Inc. |
| K170892 | Liofilchem MIC Test Strip (MTS)- Tedizolid 0.002 - 32 µg/mL | May 25, 2017 | Substantially Equivalent | Liofilchem s.r.l. |
| K163517 | Liofilchem MIC Test Strip (MTS) Telavancin 0.016 - 256.0 µg/mL | Mar 14, 2017 | Substantially Equivalent | Liofilchem s.r.l. |
| K163298 | Liofilchem MIC Test Strip (MTS) Ceftazidime 0.016 - 256.0 µg/mL | Feb 22, 2017 | Substantially Equivalent | Liofilchem s.r.l. |
| K162854 | Liofilchem MIC Test Strip (MTS) Meropenem 0.002-32.0 ug/ml | Dec 19, 2016 | Substantially Equivalent | Liofilchem s.r.l. |
| K161175 | Liofilchem MIC Test Strip (MTS)- Ceftolozane/Tazobactam 0.016/4 - 256/4 mcg/mL | Jul 12, 2016 | Substantially Equivalent | Liofilchem s.r.l. |
| K153569 | Liofilchem MIC Test Strip (MTS) -Dalbavancin at 0.002 - 32 ug/ml | Jun 22, 2016 | Substantially Equivalent | Liofilchem s.r.l. |
| K153687 | Liofilchem MIC Test Strip (MTS)-Vancomycin 0.016 -256 ug/mL | Mar 31, 2016 | Substantially Equivalent | Liofilchem s.r.l. |
| K152774 | The Sensititre 18-24 hour MIC or Breakpoint Susceptibility System with Ceftazidime/Avibactam in the dilutions range of 0.015/4 - 32/4 ug/mL | Dec 21, 2015 | Substantially Equivalent | Thermo Fisher Scientific |
| K151873 | Etest Ceftaroline (0.002 - 32ug/ml) | Oct 07, 2015 | Substantially Equivalent | Biomerieux S.A. |
| K152346 | MicroScan Dried Gram Positive MIC/Combo Panels - Vancomycin (0.25-64 ug/mL) | Sep 16, 2015 | Substantially Equivalent | Beckman Coulter, Inc. |
| K150556 | Sensititre 18-24 hours MIC or BP Susceptibility System with Ceftolozane/tazobactam (0.03/4- 64/4ug/mL) | Aug 28, 2015 | Substantially Equivalent | Thermo Fisher Scientific |
| K150236 | Sensititre 18 - 24 hour MIC or Breakpoint Susceptibility System with Dalbavancin (0.0005 - 2ug/mL) | Jul 27, 2015 | Substantially Equivalent | Thermo Fisher Scientific |
| K143288 | Sensititre Susceptibility plates | Apr 01, 2015 | Substantially Equivalent | Thermo Fisher Scientific |
| K143526 | The Sensititre HP MIC Susceptibility plate with Oritavancin (0.0005-8mcg/ml) | Mar 05, 2015 | Substantially Equivalent | Thermo Fisher Scientific |
| K142338 | Sensititre HP MIC Susceptibility Plate with Tedizolid (0.002-4 mcg/ml) | Mar 02, 2015 | Substantially Equivalent | Thermo Fisher Scientific |
| K143381 | Sensititre Susceptibility Plates | Feb 19, 2015 | Substantially Equivalent | Thermo Fisher Scientific |
| K142151 | SENSITITRE 18-24 HOUR SUSCEPTIBILITY PLATES | Dec 23, 2014 | Substantially Equivalent | Thermo Fisher Scientific |
| K141651 | SENSITITRE SUSCEPTIBILITY PLATES | Oct 21, 2014 | Substantially Equivalent | Thermo Fisher Scientific |
| K133847 | SENSITITRE HAEMOPHILUS / STREPTOCOCCUS PNEUMONIAE (HP) SUSCEPTIBILITY PLATES | Aug 01, 2014 | Substantially Equivalent | Thermo Fisher Scientific |
| K141000 | SENSITITRE SUSCEPTIBILITY PLATES | Jul 16, 2014 | Substantially Equivalent | Thermo Fisher Scientific |
| K140985 | SENSITITRE HAEMOPHILUS/STREPTOCOCCUS PNEUMONIAE(HP) SUSCEPTIBILITY PLATES | Jun 10, 2014 | Substantially Equivalent | Thermo Fisher Scientific |
| K133773 | SENSITITRE 18-24 HOUR MIC SUCEPTIBILITY SYSTEM | Feb 27, 2014 | Substantially Equivalent | Thermo Fisher Scientific |
| K121002 | ETEST CEFTAROLINE | Oct 12, 2012 | Substantially Equivalent | bioMerieux, Inc. |
| K112276 | VIZION | Nov 16, 2011 | Substantially Equivalent | Trek Diagnostic Systems |
| K111615 | SENSITITRE 18-24 HR SUSCEPTIBILITY PLATES | Nov 08, 2011 | Substantially Equivalent | Trek Diagnostic Systems |
| K111429 | SENSITITRE (R) HP MIC SUSCEPTIBILITY PLATE WITH CEFAROLINE (0.004-8UG/ML) AND THE SENSITITRE (R) 18-24 HOUR MIC SUSCE... | Aug 18, 2011 | Substantially Equivalent | Trek Diagnostic Systems, Ltd. |
| K102535 | ETEST TELAVANCIN IN 0.002-32 UG/ML AND 0.016-256 UG/ML | May 16, 2011 | Substantially Equivalent | Biomerieux S.A. |
| K102668 | ETEST TOBRAMYCIN 0.016-256 UG/ML AND 0.064-1024 UG/ML | Nov 17, 2010 | Substantially Equivalent | BIOMERIEUX |
| K093604 | ETEST MOXIFLOXACIN 0.002-32 UG/ML | Aug 25, 2010 | Substantially Equivalent | Ab Biomerieux |
| K093741 | SENSITIVE HAEMOPHILUS INFLUENZAE, STREPTOCOCCUS PNEUMONIA, (HP) MIC SUSCEPTIBILITY PLATES | Feb 25, 2010 | Substantially Equivalent | Trek Diagnostic Systems, Ltd. |
| K093865 | SENSITITRE 18-24HR SUSCEPTIBILITY PLATES | Feb 17, 2010 | Substantially Equivalent | Trek Diagnostic Systems, Inc. |
| K092445 | SENSITITRE 18-24 HOUR SUSCEPTIBILITY PLATES | Dec 16, 2009 | Substantially Equivalent | Trek Diagnostic Systems, Ltd. |
| K083606 | SENSITITRE 18-24 HOUR SUSECEPTIBILITY PLATES | Mar 24, 2009 | Substantially Equivalent | Trek Diagnostic Systems, Inc. |
| K081520 | SENSITITRE VIZION | Oct 24, 2008 | Substantially Equivalent | Trek Diagnostic Systems, Inc. |
| K081182 | MICROSCAN DRIED GRAM-POSITIVE MIC/COMBO PANELS NEW ANTIMICROBIAL TEST - INDUCIBLE CLINDAMYCIN | Aug 08, 2008 | Substantially Equivalent | Siemens |
| K081325 | ETEST DORIPENEM - ANTIMICROBIAL SUSCEPTIBILITY TEST - MIC AT 0.002-32 UG/ML | Jul 24, 2008 | Substantially Equivalent | Ab Biodisk |
| K073653 | SENSITITRE 18 - 24 HOUR SUSCEPTIBILITY PLATE | Mar 20, 2008 | Substantially Equivalent | Trek Diagnostic Systems, Inc. |
| K073558 | SENSITITRE 18-24 SUSCEPTIBILITY PLATE | Mar 13, 2008 | Substantially Equivalent | Trek Diagnostic Systems, Inc. |
| K073424 | SENSITITRE 18-24 HOUR SUSCEPTIBILITY PLATES | Jan 22, 2008 | Substantially Equivalent | Trek Diagnostic Systems, Inc. |
| K062841 | SENSITITRE HAEMOPHILUS/STREPTOCOCCUS PNEUMONIAE (HP) MIC AND SUSCEPTIBILITY PLATES | Dec 20, 2006 | Substantially Equivalent | Trek Diagnostic Systems, Inc. |
| K062839 | MODIFICATION TO SENSITITRE HAEMOPHILUS/STREPTOCOCCUS PNEUMONIAE (HP) MIC PLATE | Nov 09, 2006 | Substantially Equivalent | Trek Diagnostic Systems, Inc. |
| K062816 | SENSITITRE HAEMOPHILUS/STREPTOCOCCUS PNEUMONIAE (HP) MIC PLATE | Nov 01, 2006 | Substantially Equivalent | Trek Diagnostic Systems, Inc. |
| K062783 | SENSITITRE HAEMOPHILUS/STREPTOCOCCUS PNEUMONIAE (HP) MIC PLATE | Oct 26, 2006 | Substantially Equivalent | Trek Diagnostic Systems, Inc. |
| K062722 | SENSITITRE HAEMOPHILUS/STREPTOCOCCUS PNEUMONIAE (HP) MIC PLATE | Oct 20, 2006 | Substantially Equivalent | Trek Diagnostic Systems, Inc. |
| K062681 | SENSITITRE HAEMOPHILUS/STREPTOCOCCUS PNEUMONIAE (HP) MIC PLATE | Oct 13, 2006 | Substantially Equivalent | Trek Diagnostic Systems, Ltd. |
| K062022 | HAEMOPHILUS/STREPTOCOCCUS PNEUMONIAE (HP) MIC PLATE | Sep 11, 2006 | Substantially Equivalent | Trek Diagnostic Systems, Inc. |
| K062190 | SENSITITRE HAEMOPHILUS / STREPTOCOCCUS PNEUMONIAE (HP) MIC PLATES | Aug 31, 2006 | Substantially Equivalent | Trek Diagnostic Systems, Inc. |
| K061687 | MICROSCAN DRIED GRAM NEGATIVE MIC/COMBO PANELS | Jul 21, 2006 | Substantially Equivalent | Dade Behring, Inc. |
| K061536 | MICROSCAN DRIED GRAM NEGATIVE MIC/COMBO PANELS | Jul 18, 2006 | Substantially Equivalent | Dade Behring, Inc. |
| K060783 | SUSCEPTIBILITY TEST PLATE FOR VANCOMYCIN VRSA LIMITATION REMOVAL | May 16, 2006 | Substantially Equivalent | Trek Diagnostic Systems, Inc. |
| K060621 | SUSCEPTIBILITY TEST PLATE FOR ERTAPENEM 0.002-16UG/ML FOR GRAM NEGATIVE. SUSCEPTIBILITY TEST PLATE FOR ERTAPENEM 0.015- | Apr 21, 2006 | Substantially Equivalent | Tds Holdings, Inc. |
| K052366 | ETEST TIGECYCLINE GRAM POSITIVE AND GRAM NEGATIVE AEROBIC BACTERIA, STREPTOCOCCUS SPP. AND ANAEROBIC BACTERIA | Oct 13, 2005 | Substantially Equivalent | Ab Biodisk |
| K052091 | SENSITIRE SUSCEPTIBILITY PLATES- ADDITIONAL ANTIMICROBICS | Sep 21, 2005 | Substantially Equivalent | Trek Diagnostic Systems, Inc. |
| K051202 | DRIED GRAM-POSITIVE MIC/COMBO PANELS | Jun 23, 2005 | Substantially Equivalent | Dade Behring, Inc. |
| K043589 | MICROSCAN DRIED GRAM-POSITIVE MIC/COMBO PANELS - ERTAPENEM | Feb 14, 2005 | Substantially Equivalent | Dade Microscan, Inc. |
| K042392 | DAPTOMYCIN | Dec 13, 2004 | Substantially Equivalent | Ab Biodisk |
| K042390 | ETEST FOR GEMIFLOXACIN | Nov 19, 2004 | Substantially Equivalent | Ab Biodisk |
| K042331 | PASCO MIC AND MIC/ID PANELS | Oct 07, 2004 | Substantially Equivalent | Pasco Laboratories, Inc. |
| K041776 | PASCO MIC AND MIC/ID PANELS | Aug 03, 2004 | Substantially Equivalent | Pasco Laboratories, Inc. |
| K041534 | SENSITITRE HAEMOPHILUS/STREPTOCOCCUS PNEUMONIAE (HP) MIC SUSCEPTIBILITY PLATE AND SUSCEPTIBILITY TEST PANEL | Jul 27, 2004 | Substantially Equivalent | Trek Diagnostic Systems, Ltd. |
| K041214 | PASCO MIC AND MIC/ID PANELS | Jun 07, 2004 | Substantially Equivalent | Pasco Laboratories, Inc. |
| K040846 | SENSITITRE HAEMOPHILUS/STREPTOCOCCUS PNEUMONIAE (HP) MIC PLATES | Apr 26, 2004 | Substantially Equivalent | Trek Diagnostic Systems, Inc. |
| K040619 | SENSITITRE HAEMOPHILUS/STREPTOCOCCUS PNEUMONIAE (HP) MIC PLATES | Apr 07, 2004 | Substantially Equivalent | Trek Diagnostic Systems, Inc. |
| K032706 | MICROSCAN DRIED GRAM-NEGATIVE MIC/COMBO PANELS WITH ERTAPENEM (0.002-32 MCG/ML | Feb 10, 2004 | Substantially Equivalent | Dade Behring, Inc. |
| K033522 | SENSITITRE 18-24 HOURS SUSCEPTIBILITY PLATES | Feb 03, 2004 | Substantially Equivalent | Trek Diagnostic Systems, Inc. |
| K033119 | PASCO MIC AND MIC/ID PANELS | Nov 18, 2003 | Substantially Equivalent | Pasco Laboratories, Inc. |
| K032518 | PASCO MIC AND MIC/ID PANELS, GEMIFLOXACIN (STREP) | Sep 15, 2003 | Substantially Equivalent | Bd Diagnostic Systems |
| K032382 | SENSITITRE HAEMOPHILUS/STREPTOCOCCUS PNEUMONIAE (HP) MIC PLATES | Aug 29, 2003 | Substantially Equivalent | Trek Diagnostic Systems, Inc. |
| K032259 | PASCO MIC AND MIC/ID PANELS | Aug 19, 2003 | Substantially Equivalent | Bd Diagnostic Systems |
| K031727 | PASCO MIC AND MIC/ID PANELS, GEMIFLOXACIN | Jul 30, 2003 | Substantially Equivalent | Pasco Laboratories, Inc. |
| K031545 | SENSITITRE 18-24 HOUR SUSCEPTIBILITY PLATE | Jul 16, 2003 | Substantially Equivalent | Trek Diagnostic Systems, Inc. |
| K031205 | PASCO MIC AND MIC/ID PANELS | Jun 13, 2003 | Substantially Equivalent | Pasco Laboratories, Inc. |
| K031103 | PASCO MIC AND MIC/ID PANELS (ERTAPENEM) | Jun 12, 2003 | Substantially Equivalent | Pasco Laboratories, Inc. |
| K030933 | PASCO MIC AND MIC/ID PANELS | May 01, 2003 | Substantially Equivalent | Pasco Laboratories, Inc. |
| K023202 | MICROSCAN SYNERGIES PLUS | Oct 23, 2002 | Substantially Equivalent | Dade Microscan, Inc. |
| K022656 | SENSITITRE 18-24 HOURS SUSCEPTIBILITY PLATES | Oct 08, 2002 | Substantially Equivalent | Trek Diagnostic Systems, Inc. |
| K022775 | SENSITITRE 18-24 HOURS SUSCEPTIBILITY PLATES | Sep 25, 2002 | Substantially Equivalent | Trek Diagnostic Systems, Inc. |
| K021997 | SENSITITRE HAEMOPHILUS/STREPTOCOCCUS PNEUMONIAE (HP) MIC PLATE | Sep 25, 2002 | Substantially Equivalent | Trek Diagnostic Systems, Inc. |
| K021627 | SENSITITRE HAEMOPHILUS/STREPTOCOCCUS PNEUMONIAE (HP) MIC PLATE | Jun 20, 2002 | Substantially Equivalent | Trek Diagnostic Systems, Inc. |
| K021181 | MICROSCAN MICROSTREP PLUS PANEL NEW ANTICROBIAL-CLARITHROMYCIN | Jun 17, 2002 | Substantially Equivalent | Dade Microscan, Inc. |
| K021018 | MICROSCAN MICROSTREP PLUS PANEL - CHLORAMPHENICOL | Jun 11, 2002 | Substantially Equivalent | Dade Microscan, Inc. |
| K021445 | ETEST CEFDITOREN FOR S. PNEUMONIAE AND H. INFLUENZAE | Jun 06, 2002 | Substantially Equivalent | Ab Biodisk |
| K021188 | MICROSCAN MICROSTREP PLUS PANEL NEW ANTIMICROBIAL-CEFEPIME | Jun 06, 2002 | Substantially Equivalent | Dade Microscan, Inc. |
| K021169 | MICROSTREP PLUS PANEL, AZITHROMYCIN | Jun 06, 2002 | Substantially Equivalent | Dade Microscan, Inc. |
| K021110 | MICROSCAN MICROSTREP PLUS PANEL NEW ANTIMICROBIAL- CEFTRIAXONE | Jun 06, 2002 | Substantially Equivalent | Dade Microscan, Inc. |
| K020938 | MICROSCAN MICROSTREP PLUS PANEL-MEROPENEM | Jun 03, 2002 | Substantially Equivalent | Dade Microscan, Inc. |
| K020859 | CEFOTAXIME | May 15, 2002 | Substantially Equivalent | Trek Diagnostic Systems, Inc. |
| K021339 | HAEMOPHILUS/STREPTOCOCCUS PNEUMONIAE | May 09, 2002 | Substantially Equivalent | Trek Diagnostic Systems, Inc. |
| K020820 | MICROSCAN MICROSTEP PLUS PANEL NEW ANTIMICROBIAL - CEFUROXIME | May 09, 2002 | Substantially Equivalent | Dade Behring, Inc. |
| K020762 | GATIFLOXIN | May 09, 2002 | Substantially Equivalent | Trek Diagnostic Systems, Inc. |
| K020822 | MICROSCAN MICROSTEP PLUS PANEL NEW ANTIMICROBIAL - VANCOMYCIN | May 08, 2002 | Substantially Equivalent | Dade Behring, Inc. |
| K021037 | MICROSTREP PLUS PANEL WITH AMPICILLIN | May 06, 2002 | Substantially Equivalent | Dade Behring, Inc. |
| K020937 | MICROSCAN MICROSTREP PLUS PANEL-AMOXICILLIN/CLAVULANIC ACID | May 06, 2002 | Substantially Equivalent | Dade Microscan, Inc. |
| K020691 | MICROSCAN MICROSTREP PLUS PANEL NEW ANTIMICROBIAL - CEFACLOR | Apr 30, 2002 | Substantially Equivalent | Dade Microscan, Inc. |
| K020686 | MICROSCAN MICROSTREP PLUS PANEL NEW ANTIMICROBIAL - TRIMETHOPRIM/SULFAMETHOXAZOLE | Apr 30, 2002 | Substantially Equivalent | Dade Microscan, Inc. |
| K020748 | ETEST ERTAPENEM | Apr 29, 2002 | Substantially Equivalent | Ab Biodisk |
| K020556 | MICROSCAN MICROSTREP PLUS PANEL WITH LEVOFLOXACIN | Apr 26, 2002 | Substantially Equivalent | Dade Microscan, Inc. |
| K014259 | SENSITITRE HEAMOPHILUS/STREPTOCOCCUS PNEUMONIAE (HP) MIC PLATE | Mar 26, 2002 | Substantially Equivalent | Trek Diagnostic Systems, Inc. |
| K020037 | DRIED GRAM NEGATIVE MIC/COMBO PANELS | Mar 22, 2002 | Substantially Equivalent | Dade Microscan, Inc. |
| K020331 | PASCO MIC AND MIC/ID PANELS | Mar 20, 2002 | Substantially Equivalent | Pasco Laboratories, Inc. |
| K020162 | DRIED GRAM-POSITIVE MIC/COMBO PANELS WITH PENICILLIN | Mar 14, 2002 | Substantially Equivalent | Dade Behring, Inc. |
| K014258 | SENSITITRE HAEMOPHILUS/STREPTOCOCCUS PNEUMONIAE (HP) MIC PLATE | Feb 19, 2002 | Substantially Equivalent | Trek Diagnostic Systems, Inc. |
| K013925 | SENSITITRE HAEMOPHILUS/STREPTOCOCCUS PNEUMONIAE (HP) MIC SUSCEPTIBILITY PLATES | Dec 21, 2001 | Substantially Equivalent | Trek Diagnostic Systems, Inc. |
| K013580 | SENSITITRE HAEMOPHILUS/STREPTOCOCCUS PNEUMONIAE (HP) MIC SUSCEPTIBILITY PLATE | Dec 12, 2001 | Substantially Equivalent | Trek Diagnostic Systems, Inc. |
| K013423 | MICROSCAN DRIED GRAM NEGATIVE OVERNIGHT MIC/COMBO PANELS | Dec 12, 2001 | Substantially Equivalent | Dade Microscan, Inc. |
| K013075 | SENSITITRE HAEMOPHILUS/STREPTOCOCCUS PNEUMONIAE (HP) MIC PLATE | Nov 26, 2001 | Substantially Equivalent | Trek Diagnostic Systems, Inc. |
| K012921 | SENSITITRE HAEMOPHILUS/STREPTOCOCCUS PNEUMONIAE (HP) MIC PLATE | Nov 02, 2001 | Substantially Equivalent | Trek Diagnostic Systems, Inc. |
| K012895 | HEAMOPHILUS/STREPTOCOCCUS PNEUMONIAE | Oct 30, 2001 | Substantially Equivalent | Trek Diagnostic Systems, Inc. |
| K012565 | SENSITITRE HAEMOPHILUS/STREPTOCOCCUS PNEUMONIAE (HP) MIC PLATE | Sep 12, 2001 | Substantially Equivalent | Trek Diagnostic Systems, Inc. |
| K012151 | HAEMOPHILUS/STREPTOCOCCUS PNEUMONIAE (HP) MIC PLATE | Aug 29, 2001 | Substantially Equivalent | Trek Diagnostic Systems, Inc. |
| K011803 | SENSITITRE 18 - 24 HOURS SUSCEPTIBILITY PLATES | Aug 15, 2001 | Substantially Equivalent | Trek Diagnostic Systems, Inc. |
| K010363 | ETEST MEROPENEM | Apr 09, 2001 | Substantially Equivalent | Ab Biodisk |
| K004045 | SUSCEPTIBILITY TEST PANEL | Mar 06, 2001 | Substantially Equivalent | Trek Diagnostic Systems, Inc. |
| K003868 | SENSITITRE SUSCEPTIBILITY PLATES-ADDITIONAL ANTIMICROBICS | Feb 27, 2001 | Substantially Equivalent | Trek Diagnostic Systems, Inc. |
| K003834 | SENSITITRE SUSCEPTIBILITY PLATES-ADDITIONAL ANTIMICROBICS | Feb 23, 2001 | Substantially Equivalent | Trek Diagnostic Systems, Inc. |
| K001953 | PASCO MIC AND MIC/ID PANELS | Aug 10, 2000 | Substantially Equivalent | Pasco Laboratories, Inc. |
| K001887 | MODIFICATION TO PASCO MIC AND MIC/ID PANELS | Aug 09, 2000 | Substantially Equivalent | Pasco Laboratories, Inc. |
| K001547 | ETEST ESBL CT/CTL STRIP; ETEST ESBL TZ/TZL STRIP | Aug 07, 2000 | Substantially Equivalent | Ab Biodisk |
| K001558 | SENSITITRE 18-24 HOURS SUSCEPTIBILITY PLATES (QUINUPRISTIN/DALFOPRISTIN) | Jul 24, 2000 | Substantially Equivalent | Trek Diagnostic Systems, Inc. |
| K001612 | PASCO MIC AND MIC/ID PANELS | Jul 18, 2000 | Substantially Equivalent | Pasco Laboratories, Inc. |
| K001573 | SENSITITRE 18-24 HOURS SUSCEPTIBILITY PLATES | Jul 18, 2000 | Substantially Equivalent | Trek Diagnostic Systems, Inc. |
| K001516 | PASCO MIC AND MIC/ID PANELS | Jul 12, 2000 | Substantially Equivalent | Pasco Laboratories, Inc. |
| K001036 | SENSITITRE 18-24 HOURS SUSCEPTIBILITY PLATES (MOXIFLOXACIN) | Jun 06, 2000 | Substantially Equivalent | Trek Diagnostic Systems, Inc. |
| K001035 | SENSITITRE 18-24 HOURS SUSCEPTIBILITY PLATES (GATIFLOXACIN) | May 23, 2000 | Substantially Equivalent | Trek Diagnostic Systems, Inc. |
| K000596 | ETEST GATIFLOXACIN | May 22, 2000 | Substantially Equivalent | Ab Biodisk |
| K000298 | ETEST MOXIFLOXACIN | May 18, 2000 | Substantially Equivalent | Ab Biodisk |
| K983943 | MICROSTREP PLUS PANEL, LEVOFLOXACIN | Feb 18, 2000 | Substantially Equivalent | Dade Microscan, Inc. |
| K993679 | MICROSTREP PLUS PANEL - HAEMOPHILUS/AMPICILLIN | Jan 14, 2000 | Substantially Equivalent | Dade Microscan, Inc. |
| K983953 | MICROSTREP PLUS PANEL, VANCOMYCIN | Jan 14, 2000 | Substantially Equivalent | Dade Microscan, Inc. |
| K983746 | MICROSTREP PLUS PANEL | Dec 09, 1999 | Substantially Equivalent | Dade Microscan, Inc. |
| K992296 | PASCO MIC AND MIC/ID PANELS, VANCOMYCIN | Sep 21, 1999 | Substantially Equivalent | Pasco Laboratories, Inc. |
| K992143 | MODIFICATION TO PASCO MIC AND MIC/ID PANELS (CLINDAMYCIN) | Sep 16, 1999 | Substantially Equivalent | Pasco Laboratories, Inc. |
| K992108 | PASCO MIC AND MIC/ID PANELS (CEFEPIME) | Sep 03, 1999 | Substantially Equivalent | Pasco Laboratories, Inc. |
| K992059 | PASCO MIC AND MIC/ID PANELS | Aug 30, 1999 | Substantially Equivalent | Pasco Laboratories, Inc. |
| K991925 | PASCO MIC AND MIC/ID PANELS | Aug 26, 1999 | Substantially Equivalent | Pasco Laboratories, Inc. |
| K983922 | DRIED GRAM-NEGATIVE AND GRAM-POSITIVE MIC/COMBO PANELS | Jun 17, 1999 | Substantially Equivalent | Dade Microscan, Inc. |
| K983408 | DRIED GRAM-NEGATIVE AND GRAM-POSITIVE MIC/COMBO PANELS | May 10, 1999 | Substantially Equivalent | Dade Microscan, Inc. |
| K983711 | DRIED GRAM-NEGATIVE AND GRAM-POSITIVE MIC/COMBO PANELS | Apr 27, 1999 | Substantially Equivalent | Dade Microscan, Inc. |
| K990722 | ETEST FOR CEFUROXIME | Apr 22, 1999 | Substantially Equivalent | Ab Biodisk |
| K990685 | TRIMETHOPRIM/SULPHAMETHOXAZOLE (1/19) | Mar 26, 1999 | Substantially Equivalent | Ab Biodisk |
| K990297 | ETEST MINOCYCLINE | Mar 22, 1999 | Substantially Equivalent | Ab Biodisk |
| K984581 | SYSTEM U3 FOR CEPHALOTHIN | Mar 09, 1999 | Substantially Equivalent | Ab Biodisk |
| K984491 | SYSTEM U3 FOR CEFUROXIME | Mar 09, 1999 | Substantially Equivalent | Ab Biodisk |
| K983890 | SYSTEM U3 | Feb 18, 1999 | Substantially Equivalent | Ab Biodisk |
| K984489 | SENSITITRE 18-24 HOUR SUSCEPTIBILITY PLATES | Feb 16, 1999 | Substantially Equivalent | Accumed Intl., Inc. |
| K984144 | SYSTEM U3 FOR AMOXICILLIN/CLAVULANIC ACID | Feb 09, 1999 | Substantially Equivalent | Ab Biodisk |
| K984087 | SYSTEM U3 FOR AMPICILLIN | Feb 08, 1999 | Substantially Equivalent | Ab Biodisk |
| K983565 | SYSTEM U3 FOR NITROFURANTOIN | Jan 05, 1999 | Substantially Equivalent | Ab Biodisk |
| K983571 | SYSTEM U3 FOR TETRACYCLINE | Dec 30, 1998 | Substantially Equivalent | Ab Biodisk |
| K983486 | SYSTEM U3 FOR NORFLOXACIN | Dec 23, 1998 | Substantially Equivalent | Ab Biodisk |
| K983301 | SENSITITRE 18-24 HOUR SUSCEPTIBILITY PLATES WITH TROVAFLOXACIN | Nov 25, 1998 | Substantially Equivalent | Accumed Intl., Inc. |
| K983259 | SYSTEM U3 FOR TRIMETHOPRIM/SULFAMETHOXAZOLE | Nov 25, 1998 | Substantially Equivalent | Ab Biodisk |
| K983252 | SYSTEM U3 FOR GENTAMICIN | Nov 20, 1998 | Substantially Equivalent | Ab Biodisk North America, Inc. |
| K983027 | TRIMETHOPRIM/SULPHAMETHOXAZOLE | Oct 02, 1998 | Substantially Equivalent | Ab Biodisk |
| K982868 | ETEST RIFAMPICIN WITH INDICATIONS FOR S. PNEUMONIAE | Sep 30, 1998 | Substantially Equivalent | Ab Biodisk |
| K981639 | SYSTEM U3 FOR CIPROFLOXACIN | Sep 03, 1998 | Substantially Equivalent | Ab Biodisk |
| K980877 | ETEST CEFDINIR | Jul 06, 1998 | Substantially Equivalent | Ab Biodisk |
| K980335 | ETEST BENZYLPENICILLIN | Jun 15, 1998 | Substantially Equivalent | Ab Biodisk |
| K981137 | ETEST CEFOTAXIME | Jun 09, 1998 | Substantially Equivalent | Ab Biodisk |
| K981136 | ETEST FOSFOMYCIN | Jun 09, 1998 | Substantially Equivalent | Ab Biodisk |
| K981135 | ETEST BENZYLPENICILLIN | Jun 09, 1998 | Substantially Equivalent | Ab Biodisk |
| K981138 | ETEST CIPROFLOXACIN | Jun 05, 1998 | Substantially Equivalent | Ab Biodisk |
| K981139 | ETEST CEFTRIAXONE | Jun 01, 1998 | Substantially Equivalent | Ab Biodisk |
| K980348 | ETEST VANCOMYCIN | May 29, 1998 | Substantially Equivalent | Ab Biodisk |
| K980342 | ETEST CHLORAMPHENICAL | May 29, 1998 | Substantially Equivalent | Ab Biodisk |
| K981134 | ETEST TETRACYCLINE | May 28, 1998 | Substantially Equivalent | Ab Biodisk |
| K980338 | ETEST OFLOXACIN | May 28, 1998 | Substantially Equivalent | Ab Biodisk |
| K980347 | ETEST TETRACYCLINE | May 27, 1998 | Substantially Equivalent | Ab Biodisk |
| K980345 | ETEST CEFTRIAXONE | May 27, 1998 | Substantially Equivalent | Ab Biodisk |
| K980773 | ETEST GREPAFLOXACIN | May 18, 1998 | Substantially Equivalent | Ab Biodisk |
| K980603 | ETEST TROVAFLOXACIN | May 13, 1998 | Substantially Equivalent | Ab Biodisk |
| K974362 | PASCO MIC AND MIC/ID PANELS | Feb 12, 1998 | Substantially Equivalent | Pasco Laboratories, Inc. |
| K973695 | PASCO MIC AND MIC/ID PANELS | Nov 05, 1997 | Substantially Equivalent | Pasco Laboratories, Inc. |
| K972688 | MICROSCAN DRIED GRAM POSITIVE MIC/COMBO PANELS LEVOFLOXACIN | Sep 08, 1997 | Substantially Equivalent | Dade Microscan, Inc. |
| K972524 | DRIED GRAM-POSITIVE MIC/COMBO PANELS | Sep 08, 1997 | Substantially Equivalent | Dade Intl., Inc. |
| K972567 | PASCO MIC AND MIC/ID PANELS | Aug 20, 1997 | Substantially Equivalent | Pasco Laboratories, Inc. |
| K971951 | PASCO MIC AND MIC/ID PANELS | Aug 15, 1997 | Substantially Equivalent | Pasco Laboratories, Inc. |
| K972180 | DRIED GRAM-NEGATIVE MIC/COMBO PANELS | Aug 01, 1997 | Substantially Equivalent | Dade Microscan, Inc. |
| K971697 | ETEST FOR LEVOFLOXACIN | Jul 14, 1997 | Substantially Equivalent | Ab Biodisk |
| K971694 | ETEST FOR CEFTAZIDIME | Jun 30, 1997 | Substantially Equivalent | Ab Biodisk |
| K971376 | DRIED GRAM-NEGATIVE MIC/COMBO PANELS | May 30, 1997 | Substantially Equivalent | Dade Microscan, Inc. |
| K970676 | DRIED GRAM-NEGATIVE MIC/COMBO PANELS | May 02, 1997 | Substantially Equivalent | Dade Intl., Inc. |
| K970473 | ETEST SUBMISSION FOR AZITHROMYCIN/S. PNEUMONIAE | May 01, 1997 | Substantially Equivalent | Ab Biodisk |
| K970210 | AMIKACIN | May 01, 1997 | Substantially Equivalent | Ab Biodisk |
| K964236 | (MODIFIED) ETEST PACKAGE INSERT | May 01, 1997 | Substantially Equivalent | Ab Biodisk |
| K970820 | ETEST SPARFLOXACIN | Apr 25, 1997 | Substantially Equivalent | Ab Biodisk |
| K965190 | SENSITITRE HAEMOPHILUS/STREPTOCOCCUS PNEUMONIAE MIC PLATE | Mar 19, 1997 | Substantially Equivalent | Accumed Intl., Inc. |
| K964203 | PIPERACILLIN/TAZOBACTAM 4 | Dec 18, 1996 | Substantially Equivalent | Ab Biodisk |
| K963641 | STREPTOCOCCUS MIC PANEL | Dec 18, 1996 | Substantially Equivalent | Dade Microscan, Inc. |
| K963107 | ETEST FOR CEFEPIME | Oct 24, 1996 | Substantially Equivalent | Ab Biodisk |
| K960991 | ETEST SUBMISSION FOR AMOXICILLIN | Oct 08, 1996 | Substantially Equivalent | Ab Biodisk |
| K962867 | SENSITITRE 18 HOUR SUSCEPTIBILITY PLATES | Sep 30, 1996 | Substantially Equivalent | Sensititre Alamar |
| K962794 | ETEST FOR AZTREONAM | Aug 30, 1996 | Substantially Equivalent | Ab Biodisk |
| K961519 | ETEST SUBMISSION FOR AZITHROMYCIN | Jul 05, 1996 | Substantially Equivalent | Ab Biodisk |
| K961517 | ETEST SUBMISSION FOR CEFOTETAN | Jul 05, 1996 | Substantially Equivalent | Ab Biodisk |
| K960990 | ETEST SUBMISSION FOR VANCOMYCIN | May 20, 1996 | Substantially Equivalent | Ab Biodisk |
| K960989 | ETEST SUBMISSION FOR IMIPENEM | May 20, 1996 | Substantially Equivalent | Ab Biodisk |
| K960235 | SENSITITRE 18 HOUR SUSCEPTIBILITY PLATES | Mar 27, 1996 | Substantially Equivalent | Accumed Intl., Inc. |
| K960220 | SENSITITRE 18 HOUR SUSCEPTIBILITY PLATES | Mar 11, 1996 | Substantially Equivalent | Sensititre , Ltd. |
| K955910 | DRIED GRAM-NEGATIVE MIC/COMBO PANELS | Feb 23, 1996 | Substantially Equivalent | Dade Microscan, Inc. |
| K955920 | THE E TEST CEFTIZOXIME | Feb 22, 1996 | Substantially Equivalent | Ab Biodisk |
| K954319 | AMOXICILLIN/CLAVULANIC ACID 2/1 | Dec 12, 1995 | Substantially Equivalent | Ab Biodisk |
| K953422 | FOX FASTIDIOUS TEST PANELS | Oct 07, 1995 | Substantially Equivalent | Micro-Media Systems, Inc. |
| K951241 | HAEMOPHILUS/PNEUMOCOCCUS MIC PLATE | Oct 07, 1995 | Substantially Equivalent | Radiometer America, Inc. |
| K951240 | JUSTONE | Oct 07, 1995 | Substantially Equivalent | Radiometer America, Inc. |
| K953223 | PIPERACILIN TAZOBACTAM 4 UG | Aug 15, 1995 | Substantially Equivalent | Ab Biodisk |
| K934458 | DRIED GRAM-POSITIVE MIC/COMBO PANELS | Jul 18, 1995 | Substantially Equivalent | Baxter Diagnostics, Inc. |
| K936305 | SENSITITRE/PIP/TA2 SUSCEPTIBILITY PLATES | Jul 13, 1995 | Substantially Equivalent | Radiometer America, Inc. |
| K951879 | TICARCILLIN/CLAVULANIC ACID 2 | Jul 07, 1995 | Substantially Equivalent | Ab Biodisk |
| K951539 | ENTEROCOCCUS SCREENING MEDIUM | Jun 13, 1995 | Substantially Equivalent | Becton Dickinson Microbiology Systems |
| K946364 | E TEST FOR OFLOXACIN | May 02, 1995 | Substantially Equivalent | Ab Biodisk |
| K950817 | DRIED GRAM POSITIVE MIC/COMBO PANELS/PNEUMOCOCCI | Apr 25, 1995 | Substantially Equivalent | Baxter Diagnostics, Inc. |
| K950328 | AMOXICILLIN/CLAVULANIC ACID 2/1 | Apr 14, 1995 | Substantially Equivalent | Ab Biodisk North America, Inc. |
| K950123 | SCEPTOR SYSTEM PANELS | Mar 23, 1995 | Substantially Equivalent | Becton Dickinson Microbiology Systems |
| K945433 | ETEST/CEFTRIAXONE/HAEMOPHILUS/PNEUMOCOCCUS | Mar 17, 1995 | Substantially Equivalent | Ab Biodisk |
| K944753 | SENSITITRE SUSCEPTIBILITY ENTEROCOCCAL VANCO AMP | Feb 24, 1995 | Substantially Equivalent | Radiometer America, Inc. |
| K943756 | MICRODILUTION DEVICE FOR DETERMINING GENTAMICIN & STRRPTOMYCIN FOR DETECTION OF HIGH LEVEL AMINOGLYCOSIDE RESISTANCE | Feb 17, 1995 | Substantially Equivalent | Alamar Biosciences, Inc. |
| K945997 | MODIFIED FOX EXTRA GRAM POSITIVE | Feb 16, 1995 | Substantially Equivalent | Micro-Media Systems, Inc. |
| K935485 | FAS FASTIDIOUS MIC PANEL | Feb 16, 1995 | Substantially Equivalent | Microtech Medical Systems, Inc. |
| K940917 | LORACARBEF GRAM-NAGATIVE PANELS | Feb 08, 1995 | Substantially Equivalent | Baxter Diagnostics, Inc. |
| K941459 | GRAM POSITIVE DRIED OVERNIGHT PANELS/LOMEFLOX | Feb 03, 1995 | Substantially Equivalent | Baxter Diagnostics, Inc. |
| K941317 | DRIED GRAM NEGATIVE/CEFMETAZOLE | Jan 31, 1995 | Substantially Equivalent | Baxter Diagnostics, Inc. |
| K941997 | BBL CRYSTAL MRSA ID SYSTEM | Jan 27, 1995 | Substantially Equivalent | Becton Dickinson Microbiology Systems |
| K946126 | PASCO MIC AND MIC/ID PANELS | Jan 17, 1995 | Substantially Equivalent | Pasco Laboratories, Inc. |
| K942267 | DRIED GRAM-POSITIVE MIC/COMBO PANELS/CEFMETAZOLE | Jan 09, 1995 | Substantially Equivalent | Baxter Diagnostics, Inc. |
| K942089 | MICRODILUTION/LORACARBEF PANELS | Jan 09, 1995 | Substantially Equivalent | Baxter Diagnostics, Inc. |
| K943510 | DRIED GRAM-POSITIVE MIC/COMBO PANELS | Dec 02, 1994 | Substantially Equivalent | Baxter Diagnostics, Inc. |
| K944651 | DRIED GRAM-POSITIVE MIC/COMBO PANELS | Nov 18, 1994 | Substantially Equivalent | Baxter Diagnostics, Inc. |
| K935519 | ETEST FOR AMPICILLIN/SULBACTAM 2/1 | Nov 04, 1994 | Substantially Equivalent | Ab Biodisk North America, Inc. |
| K944723 | ANTIMICROBIAL SUSCEPTIBILITY TEST PANEL MODIFICATION | Oct 21, 1994 | Substantially Equivalent | Alamar Biosciences, Inc. |
| K944517 | PASCO MIC AND MIC/ID PANELS | Oct 19, 1994 | Substantially Equivalent | Pasco Laboratories, Inc. |
| K934323 | DRIED GRAM-POSITIVE MIC/COMBO PANELS, AMP/EXT DIL | Oct 19, 1994 | Substantially Equivalent | Baxter Diagnostics, Inc. |
| K934380 | PASCO MIC PANELS/ GENT & STREP SYNERGY | Jan 27, 1994 | Substantially Equivalent | Pasco Laboratories, Inc. |
| K933746 | PASCO MIC AND MIC/ID PANELS | Dec 27, 1993 | Substantially Equivalent | Pasco Laboratories, Inc. |
| K933709 | PASCO MIC AND MIC/ID PANELS | Dec 27, 1993 | Substantially Equivalent | Pasco Laboratories, Inc. |
| K933885 | ALAMAR BIOSCIENCES LABORATORY, INC. ANTIMICROBIAL SUSCEPTIBILITY TEST PANEL | Nov 16, 1993 | Substantially Equivalent | Alamar Biosciences, Inc. |
| K933849 | PASCO MIC AND MIC/ID PANELS | Nov 16, 1993 | Substantially Equivalent | Pasco Laboratories, Inc. |
| K932917 | PASCO MIC AND MIC/ID PANELS | Aug 18, 1993 | Substantially Equivalent | Pasco Laboratories, Inc. |
| K932082 | DRIED GRAM-NEGATIVE MIC/COMBO PANELS | Jul 20, 1993 | Substantially Equivalent | Baxter Diagnostics, Inc. |
| K930469 | ANTIMICROBIAL SUSCEPTIBILITY TEST PANEL | Jun 25, 1993 | Substantially Equivalent | Alamar Biosciences Laboratory, Inc. |
| K926294 | BBL CRYSTAL MRSA ID SYSTEM | May 18, 1993 | Substantially Equivalent | Becton Dickinson Microbiology Systems |
| K931069 | PASCO MIC AND MIC/ID PANELS | May 12, 1993 | Substantially Equivalent | Pasco Laboratories, Inc. |
| K930055 | ANTIMICROBIAL SUSCEPTIBILITY TEST PANEL | Apr 05, 1993 | Substantially Equivalent | Alamar Biosciences Laboratory, Inc. |
| K926545 | DRIED GRAM-NEGATIVE MIC/COMBO PANELS | Mar 26, 1993 | Substantially Equivalent | Baxter Diagnostics, Inc. |
| K923045 | SENSITITRE SUSCEPTIBILITY PLATES | Mar 09, 1993 | Substantially Equivalent | Radiometer America, Inc. |
| K925644 | CATION ADJUSTED MUELLER HINTON BROTH | Jan 15, 1993 | Substantially Equivalent | Pasco Laboratories, Inc. |
| K922458 | DRIED GRAM-NEGATIVE AND POSITIVE MIC/COMBO PANELS | Dec 11, 1992 | Substantially Equivalent | Baxter Healthcare Corp |
| K923684 | API UNISCEPT MIC/TYPE 2 AND 3 AND MICRO MIC | Dec 03, 1992 | Substantially Equivalent | Analytical Products, Inc. |
| K924500 | ANTIMICROBIAL SUSCEPTIBILITY TEST | Nov 30, 1992 | Substantially Equivalent | Alamar Biosciences Laboratory, Inc. |
| K922926 | API UNISCEPT KB/TYPE 2 AND 3 | Oct 13, 1992 | Substantially Equivalent | Analytical Products, Inc. |
| K922780 | ANTIMICROBIAL SUSCEPTIBILITY TEST PANEL | Aug 20, 1992 | Substantially Equivalent | Alamar Biosciences Laboratory, Inc. |
| K922003 | ANTIMICROBIAL SUSCETIBILITY TEST PANEL | Aug 19, 1992 | Substantially Equivalent | Alamar Biosciences Laboratory, Inc. |
| K922168 | ANTIMICROBIAL SUSCEPTIBILITY TEST PANEL | Jul 28, 1992 | Substantially Equivalent | Alamar Biosciences Laboratory, Inc. |
| K912778 | HP-HAEMOPHILUS/PNEUMOCOCCUS MIC PLATE | Feb 18, 1992 | Substantially Equivalent | Sensititre Microbiology A Div. of Radiometer |
| K913459 | THE E TEST, MODIFICATION | Sep 25, 1991 | Substantially Equivalent | Ab Biodisk |
| K912965 | API UNISCEPT KB | Sep 06, 1991 | Substantially Equivalent | Analytab Products, Inc. |
| K912964 | API UNISCEPT MIC/UNISCEPT MICRO-MIC | Aug 29, 1991 | Substantially Equivalent | Analytab Products, Inc. |
| K912846 | JUSTONE(TM) | Aug 22, 1991 | Substantially Equivalent | Sensititre Microbiology A Div. of Radiometer |
| K912613 | GENTAMICIN 500 UG/ML TO BE INCLUDED IN JUSTONE(TM) | Aug 22, 1991 | Substantially Equivalent | Sensititre Microbiology A Div. of Radiometer |
| K911558 | ANTIMICROBIAL SUSCEPT. TEST PANEL NITROFURANTOIN | May 15, 1991 | Substantially Equivalent | Alamar Biosciences Laboratory, Inc. |
| K911392 | ANTIMICROBIAL SUSCEPTIBILITY TEST PANEL (CEFOTETAN | May 08, 1991 | Substantially Equivalent | Alamar |
| K911391 | ANTIMICROBIAL SUSCEPT. TEST PANEL (CEFTIZOXIME) | May 08, 1991 | Substantially Equivalent | Alamar |
| K911390 | ANTIMICROBIAL SUSCEPT. TEST PANEL(TRIMETHOPRIM) | May 08, 1991 | Substantially Equivalent | Alamar |
| K911389 | ANTIMICROBIAL SUSCEPTIBILITY TEST PANEL (IMIPENEM) | May 08, 1991 | Substantially Equivalent | Alamar |
| K911559 | ANTIMICROBIAL SUSCEPT. TEST PANEL CEFONICID | Apr 22, 1991 | Substantially Equivalent | Alamar Biosciences Laboratory, Inc. |
| K911557 | ANTIMICROBIAL SUSCEPT. TEST PANEL TICARCILLIN | Apr 22, 1991 | Substantially Equivalent | Alamar Biosciences Laboratory, Inc. |
| K911556 | ANTIMICROBIAL SUSCEPT. TEST PANEL TICARC./CLAVUL. | Apr 22, 1991 | Substantially Equivalent | Alamar Biosciences Laboratory, Inc. |
| K911555 | ANITIMICROBIAL SUSCEPT. TEST PANEL AMOX./CLAVUL. | Apr 22, 1991 | Substantially Equivalent | Alamar Biosciences Laboratory, Inc. |
| K911305 | ANTIMICROBIAL GENTAMICIN | Apr 22, 1991 | Substantially Equivalent | Alamar Biosciences Laboratory, Inc. |
| K911304 | ANTIMICROBIAL TOBRAMYCIN | Apr 22, 1991 | Substantially Equivalent | Alamar Biosciences Laboratory, Inc. |
| K911185 | ANTIMICROBIAL AMPICILLIN | Apr 22, 1991 | Substantially Equivalent | Alamar Biosciences Laboratory, Inc. |
| K911303 | ANTIMICROBIAL AMIKACIN | Apr 18, 1991 | Substantially Equivalent | Alamar Biosciences Laboratory, Inc. |
| K911187 | ANTIMICROBIAL CEFUROXIME | Apr 17, 1991 | Substantially Equivalent | Alamar Biosciences Laboratory, Inc. |
| K911186 | ANTIMICROBIAL AMPICILLIN/SULBACTAM | Apr 17, 1991 | Substantially Equivalent | Alamar Biosciences Laboratory, Inc. |
| K910484 | ANTIMICROBIAL SUSCEPTIBILITY TEST PANEL | Mar 11, 1991 | Substantially Equivalent | Alamar |
| K910242 | EF SYNERGY QUAD MODIFIED | Mar 05, 1991 | Substantially Equivalent | Remel Co. |
| K910346 | ANTIMICROBIAL CEFTRIAXONE | Feb 25, 1991 | Substantially Equivalent | Alamar |
| K910345 | ANTIMICROBIAL CEFOPERAZONE | Feb 25, 1991 | Substantially Equivalent | Alamar |
| K905853 | ANTIMICROBIAL SUSCEPTIBILITY TEST PANEL | Feb 07, 1991 | Substantially Equivalent | Alamar Biosciences Laboratory, Inc. |
| K904689 | ANTIMICROBIAL SUSCEPT TEST PANEL/ADD ANTIBIOTICS | Feb 07, 1991 | Substantially Equivalent | Alamar Biosciences Laboratory, Inc. |
| K904523 | ANTIMICROBIAL SUSCEPTIBILITY TEST PANEL/MODIFIED | Dec 21, 1990 | Substantially Equivalent | Alamar Biosciences Laboratory, Inc. |
| K903589 | EF SYNERGY QUAD | Nov 13, 1990 | Substantially Equivalent | Remel Co. |
| K901598 | FASTIDIOUS MIC PANEL | Nov 08, 1990 | Substantially Equivalent | Microtech Medical Systems, Inc. |
| K902739 | PASCO MIC AND MIC/ID MODIFIED | Jul 16, 1990 | Substantially Equivalent | Pasco Laboratories, Inc. |
| K896278 | SCEPTOR - NEW ANTIMICROBIAL AGENT - CEFOTETAN | Mar 07, 1990 | Substantially Equivalent | Bd Becton Dickinson Vacutainer Systems Preanalytic |
| K896566 | MODIFIED FOX EXTRA GRAM NEGATIVE AND POSITIVE | Feb 09, 1990 | Substantially Equivalent | Medical Specialties, Inc. |
| K896332 | SUPPLEMENT TO ANAEROBIC MIC PANEL | Feb 05, 1990 | Substantially Equivalent | Microtech Medical Systems, Inc. |
| K896965 | ANTIMICROBIAL SUSCEPTIBILITY TEST PANEL | Jan 29, 1990 | Substantially Equivalent | Alamar Biosciences Laboratory, Inc. |
| K895215 | PASCO MIC/ID GRAM-POSITIVE PANEL | Jan 29, 1990 | Substantially Equivalent | Difco Laboratories, Inc. |
| K895796 | API UNISCEPT KB | Nov 13, 1989 | Substantially Equivalent | Analytical Products, Inc. |
| K894514 | ANTIMICROBIAL SUSCEPTIBILITY TEST PANEL | Nov 06, 1989 | Substantially Equivalent | Alamar Biosciences Laboratory, Inc. |
| K894189 | SCEPTOR-NEW ANTIMICROBIAL AGENT:TICAR/CLAVU ACID | Oct 10, 1989 | Substantially Equivalent | Bd Becton Dickinson Vacutainer Systems Preanalytic |
| K894146 | GRAM NEGATIVE AND POSITIVE MIC/COMBO PANELS | Sep 05, 1989 | Substantially Equivalent | Baxter Healthcare Corp |
| K893977 | GRAM NEGATIVE AND POSITIVE MIC/COMBO PANELS | Aug 15, 1989 | Substantially Equivalent | Baxter Healthcare Corp |
| K884831 | ANAEROBIC MIC PANEL | Mar 27, 1989 | Substantially Equivalent | Microtech Medical Systems, Inc. |
| K884510 | MODIFICATION MICRO-MIC | Nov 22, 1988 | Substantially Equivalent | Analytical Products, Inc. |
| K884509 | MODIFICATION MIC/API UNISCEPT(R) | Nov 22, 1988 | Substantially Equivalent | Analytical Products, Inc. |
| K883800 | SCEPTOR GRAM-NEGATIVE BREAKPOINT/ID PANEL | Oct 12, 1988 | Substantially Equivalent | Bd Becton Dickinson Vacutainer Systems Preanalytic |
| K883798 | SCEPTOR GRAM-POSITIVE BREAKPOINT/ID PANEL | Oct 12, 1988 | Substantially Equivalent | Bd Becton Dickinson Vacutainer Systems Preanalytic |
| K883551 | SCEPTOR STAPHYLOCOCCUS MIC/ID PANEL #80325 | Sep 27, 1988 | Substantially Equivalent | Bd Becton Dickinson Vacutainer Systems Preanalytic |
| K883555 | SCEPTOR RESISTANT GRAM-NEGATIVE MIC/ID #80332 | Sep 26, 1988 | Substantially Equivalent | Bd Becton Dickinson Vacutainer Systems Preanalytic |
| K883554 | SCEPTOR PSEUDOMONAS PLUS MIC/ID PANEL #80329 | Sep 26, 1988 | Substantially Equivalent | Bd Becton Dickinson Vacutainer Systems Preanalytic |
| K883553 | SCEPTOR RESISTANT GRAM-NEGATIVE MIC PANEL #80331 | Sep 26, 1988 | Substantially Equivalent | Bd Becton Dickinson Vacutainer Systems Preanalytic |
| K883552 | SCEPTOR PSEUDOMONAS PLUS MIC PANEL CAT.# 80328 | Sep 26, 1988 | Substantially Equivalent | Bd Becton Dickinson Vacutainer Systems Preanalytic |
| K883550 | SCEPTOR STAPHYLOCOCCUS MIC #80324 | Sep 26, 1988 | Substantially Equivalent | Bd Becton Dickinson Vacutainer Systems Preanalytic |
| K883549 | SCEPTOR STREPTOCOCCUS MIC PANEL #80322 | Sep 26, 1988 | Substantially Equivalent | Bd Becton Dickinson Vacutainer Systems Preanalytic |
| K883548 | SCEPTOR STREPTOCOCCUS MIC/ID PANEL #80323 | Sep 26, 1988 | Substantially Equivalent | Bd Becton Dickinson Vacutainer Systems Preanalytic |
| K882477 | ADDIT. DATA FOR BREAKPOINT/ID GRAM-NEG. PANEL | Sep 08, 1988 | Substantially Equivalent | Pasco Laboratories, Inc. |
| K883394 | GRAM NEGATIVE AND GRAM POSITIVE MIC/COMBO PANELS | Sep 07, 1988 | Substantially Equivalent | Baxter Healthcare Corp |
| K883076 | GRAM NEGATIVE & GRAM POSITIVE MIC/COMBO PANELS | Sep 07, 1988 | Substantially Equivalent | Baxter Healthcare Corp |
| K882909 | SCEPTOR - NEW ANTIMICROBIAL AGENT: RIFAMPIN | Aug 29, 1988 | Substantially Equivalent | Bd Becton Dickinson Vacutainer Systems Preanalytic |
| K882912 | SCEPTOR NEW ANTIMICROBIAL AGENT: IMIPENEM | Aug 17, 1988 | Substantially Equivalent | Bd Becton Dickinson Vacutainer Systems Preanalytic |
| K882911 | SCEPTOR EXTEN. OF CONCENTRATION RANGE: PENCILLIN | Aug 17, 1988 | Substantially Equivalent | Bd Becton Dickinson Vacutainer Systems Preanalytic |
| K882910 | SCEPTOR NEW ANTIMICROBIAL AGENT: AMPICILLIN/SULBAC | Aug 17, 1988 | Substantially Equivalent | Bd Becton Dickinson Vacutainer Systems Preanalytic |
| K882299 | SCEPTOR GRAM-NEGATIVE URINE ISOLATE MIC/ID PANEL | Jul 18, 1988 | Substantially Equivalent | Bd Becton Dickinson Vacutainer Systems Preanalytic |
| K881716 | SCEPTOR - NEW ANTIMICROBIAL AGENT: CEFACLOR | Jul 14, 1988 | Substantially Equivalent | Bd Becton Dickinson Vacutainer Systems Preanalytic |
| K882301 | SCEPTOR ENTERIC MIC/ID PANEL (REVISED 4/88) | Jul 12, 1988 | Substantially Equivalent | Bd Becton Dickinson Vacutainer Systems Preanalytic |
| K882300 | SCEPTOR ENTERIC MIC PANEL (REVISED 4/88) | Jul 12, 1988 | Substantially Equivalent | Bd Becton Dickinson Vacutainer Systems Preanalytic |
| K881846 | SCEPTOR- NEW ANTIMICROBIAL AGENT: NORFLOXACIN | Jul 08, 1988 | Substantially Equivalent | Bd Becton Dickinson Vacutainer Systems Preanalytic |
| K882029 | LABELING FOR REVISED PASCO MIC AND MIC/ID PANELS | Jul 06, 1988 | Substantially Equivalent | Pasco Laboratories, Inc. |
| K880641 | SENSITITRE STABILITY PLATES | May 13, 1988 | Substantially Equivalent | Sensititre , Ltd. |
| K880430 | GRAM NEGATIVE MIC/COMBO PANELS | Apr 12, 1988 | Substantially Equivalent | Baxter Healthcare Corp |
| K880598 | MODIFICATIONS TO API UNISCEPT (R) KB | Mar 23, 1988 | Substantially Equivalent | Analytical Products, Inc. |
| K880617 | ADDITION OF AMPICILLIN/SULBACTAM & CIPROFLOXACIN | Mar 16, 1988 | Substantially Equivalent | Pasco Laboratories, Inc. |
| K874727 | PRECEPT(TM) CIPROFLOXACIN | Feb 18, 1988 | Substantially Equivalent | Austin Biological Laboratories |
| K874876 | GRAM - & GRAM + MIC/COMBO & BREAKPOINT/COMBO PANEL | Jan 11, 1988 | Substantially Equivalent | Baxter Healthcare Corp |
| K874466 | API UNISCEPT(R) MICRO-MIC(R) SYSTEM/UNISCEPT MIC | Dec 09, 1987 | Substantially Equivalent | Analytical Products, Inc. |
| K874426 | NEW ANTIMICRO. AGENTS:AUGMENTIN,AZTREONAM,CIPROFLO | Dec 02, 1987 | Substantially Equivalent | Bd Becton Dickinson Vacutainer Systems Preanalytic |
| K870719 | SENSIR SYSTEM | Jun 15, 1987 | Substantially Equivalent | Bd Becton Dickinson Vacutainer Systems Preanalytic |
| K870074 | GRAM NEGATIVE AND GRAM POSITIVE MIC/COMBO PANELS | Apr 14, 1987 | Substantially Equivalent | Microscan Div. Baxter Healthcare Corp. |
| K870663 | API UNISCEPT(R) MICRO-MIC(R) SYSTEM/UNISCEPT(R)MIC | Mar 23, 1987 | Substantially Equivalent | Analytical Products, Inc. |
| K864891 | API UNISCEPT (TM) KB | Feb 20, 1987 | Substantially Equivalent | Analytical Products, Inc. |
| K864493 | REVISED RESISTANT 5 MIC PANEL | Feb 02, 1987 | Substantially Equivalent | Pasco Laboratories, Inc. |
| K863776 | MICRODILUTION MIC PANELS | Feb 02, 1987 | Substantially Equivalent | American Micro Scan |
| K863847 | MIC - CONCEPT(TM) RX-2 | Dec 18, 1986 | Substantially Equivalent | Microtech Medical Systems, Inc. |
| K864069 | PRECEPT (TM) TICARCILLIN/CLAVULANIC ACID | Nov 13, 1986 | Substantially Equivalent | Austin Biological Laboratories |
| K862978 | RESISTANT 6 MIC PANEL | Sep 17, 1986 | Substantially Equivalent | Pasco Laboratories, Inc. |
| K862140 | MICRODILUTION PANELS | Jul 16, 1986 | Substantially Equivalent | American Micro Scan |
| K862560 | PRECEPT CEFTIZOXIME | Jul 11, 1986 | Substantially Equivalent | Austin Biological Laboratories |
| K862446 | PRECEPT CEFTAZIDIME | Jul 11, 1986 | Substantially Equivalent | Austin Biological Laboratories |
| K861584 | GRAM NEGATIVE COMBO PANEL TYPE 3 | Jun 17, 1986 | Substantially Equivalent | American Micro Scan |
| K861187 | SCEPTOR GRAM NEGATIVE BREAKPOINT /ID PANEL | Jun 16, 1986 | Substantially Equivalent | Bd Becton Dickinson Vacutainer Systems Preanalytic |
| K861186 | SCEPTOR GRAM POSITIVE BREAKPOINT/ID PANEL | Jun 13, 1986 | Substantially Equivalent | Bd Becton Dickinson Vacutainer Systems Preanalytic |
| K861408 | MODIFIED UNISCEPT KB LABELING AMENDMENT | May 16, 1986 | Substantially Equivalent | Analytab Products, Inc. |
| K860753 | SENSITITRE SUSCEPTIBILITY PLATES | May 06, 1986 | Substantially Equivalent | Gibco Laboratories Life Technologies, Inc. |
| K854525 | FOX FASTIDIOUS TEST PANEL | Apr 11, 1986 | Substantially Equivalent | Beckman Instruments, Inc. |
| K853805 | MICRO-MEDIA MICRODILUTION TEST PANELS | Mar 19, 1986 | Substantially Equivalent | Beckman Instruments, Inc. |
| K860369 | API UNISCEPT MICRO-MIC CEFTRIAXONE/UNISCEPT MIC | Mar 11, 1986 | Substantially Equivalent | Analytical Products, Inc. |
| K860195 | PRECEPT TRIMETHOPRIM/SULFAMETHOXAZOLE | Feb 20, 1986 | Substantially Equivalent | Austin Biological Laboratories |
| K854577 | PRECEPT AMOXICILLIN/CLAVVLANIC ACID (AUGMENTIN) | Feb 05, 1986 | Substantially Equivalent | Austin Biological Laboratories |
| K853862 | PASCO RESISTANT 5 PANEL | Jan 21, 1986 | Substantially Equivalent | Pasco Laboratories, Inc. |
| K854103 | SCEPTOR ENTERIC MIC/ID PANEL | Nov 14, 1985 | Substantially Equivalent | Bd Becton Dickinson Vacutainer Systems Preanalytic |
| K854102 | SCEPTOR ENTERIC MIC PANEL | Nov 14, 1985 | Substantially Equivalent | Bd Becton Dickinson Vacutainer Systems Preanalytic |
| K854101 | SCEPTOR GRAM POSITIVE MIC PANEL | Nov 14, 1985 | Substantially Equivalent | Bd Becton Dickinson Vacutainer Systems Preanalytic |
| K854100 | SCEPTOR GRAM POSITIVE MIC/ID PANEL | Nov 14, 1985 | Substantially Equivalent | Bd Becton Dickinson Vacutainer Systems Preanalytic |
| K854099 | SCEPTOR GRAM NEGATIVE URINE ISOLATE MIC/ID PANEL | Nov 14, 1985 | Substantially Equivalent | Bd Becton Dickinson Vacutainer Systems Preanalytic |
| K854098 | SCEPTOR PSEUDOMONAS PLUS MIC PANEL | Nov 14, 1985 | Substantially Equivalent | Bd Becton Dickinson Vacutainer Systems Preanalytic |
| K854097 | SCEPTOR PSEUDOMONAS PLUS MIC/ID PANEL | Nov 14, 1985 | Substantially Equivalent | Bd Becton Dickinson Vacutainer Systems Preanalytic |
| K850833 | PRECEPT TM MEZLOCILLIN | Sep 13, 1985 | Substantially Equivalent | Austin Biological Laboratories |
| K844903 | MIC-BIO-PLATE | Dec 24, 1984 | Substantially Equivalent | Pasco Laboratories, Inc. |
| K801805 | METRONIDAZOLE DISCS | Feb 10, 1981 | Substantially Equivalent | G.D. Searle and Co. |
FEI Numbers
This FDA classification entry is associated with 9 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 9 registration numbers. Click on an entry to view related FDA registrations.