Product Code: LRG
FDA class 2
21 CFR 866.1640
Instrument For Auto Reader & Interpretation Of Overnight Suscept. Systems
Microbiology
This instrument is an automated reader and interpretation system used with overnight antimicrobial susceptibility testing panels, providing automated reading of results and interpretive reporting to guide antibiotic therapy decisions. It is classified as a Class 2 (moderate risk) device, subject to general and special controls, and requires 510(k) premarket notification before marketing. The product code is LRG, regulated under 21 CFR 866.1640, within the Microbiology medical specialty. This device is eligible for third-party review under the FDA's accredited persons program.
510(k)s
45
FEI Numbers
10
Registration Numbers
10
Unique Applicants
15
Years Active
33
Basic Information
- Product Code
- LRG
- 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 45 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K191918 | Thermo Scientific Sensititre ARIS HiQ System | Nov 06, 2019 | Substantially Equivalent | Thermo Fisher Scientific |
| K191914 | Thermo Scientific Sensititre ARIS HiQ System | Nov 06, 2019 | Substantially Equivalent | Thermo Fisher Scientific |
| K110583 | SENSITITRE OPTIREAD | Sep 22, 2011 | Substantially Equivalent | Trek Diagnostic Systems, Ltd. |
| K103532 | AUTOREADER 2 | Aug 26, 2011 | Substantially Equivalent | Trek Diagnostic Systems |
| K111677 | MICROSCAN(R) MICROSTREP PLUS(R) | Aug 04, 2011 | Substantially Equivalent | Siemens Healthcare Diagnostics, Inc. |
| K111205 | MICROSCAN (R) MICROSTREP PLUS (R) PANELS | Jul 20, 2011 | Substantially Equivalent | Siemens Healthcare Diagnostics, Inc. |
| K101425 | MICROSCAN DRIED GRAM-NEGATIVE MIC/COMBO PANEL, B1017 PANEL SERIES | Sep 10, 2010 | Substantially Equivalent | Siemens Healthcare Diagnostics |
| K081013 | MICROSCAN DRIED GRAM-POSITIVE MIC/COMBO PANELS NEW ANTIMICROBIAL TEST CEFOXITIN SCREEN | Sep 08, 2008 | Substantially Equivalent | Siemens Healthcare Diagnostics |
| K071316 | MICROSCAN SYNERGIES PLUS GRAM POSITIVE MIC/COMBO PANELS NEW ANTIMICROBIAL-STREPTOMYCIN SYNERGY SCREEN | Aug 20, 2007 | Substantially Equivalent | Dade Behring, Inc. |
| K063299 | MICROSCAN MICROSTREP PLUS PANEL-CLARITHROMYCIN | Nov 27, 2006 | Substantially Equivalent | Dade Behring, Inc. |
| K063102 | MICROSCAN MICROSTREP PLUS PANEL CEFACLOR (0.5 - 8 MCG/ML) | Nov 09, 2006 | Substantially Equivalent | Dade Behring, Inc. |
| K063101 | MICROSCAN MICROSTREP PLUS PANEL CEFOTAXIME (0.015 - 8 MCG/ML | Nov 01, 2006 | Substantially Equivalent | Dade Behring, Inc. |
| K063099 | MICROSCAN MICROSTREP PLUS PANEL CEFEPIME (O.015 - 8 MCG/ML) | Nov 01, 2006 | Substantially Equivalent | Dade Behring, Inc. |
| K063065 | MICROSCAN MICROSTREP PLUS PANEL MEROPENEM (0.03-4MCG/ML) | Oct 27, 2006 | Substantially Equivalent | Dade Behring, Inc. |
| K063064 | MICROSCAN MICROSTREP PLUS PANEL CEFTRIAXONE (0.015-8MCG/ML) | Oct 26, 2006 | Substantially Equivalent | Dade Behring, Inc. |
| K063053 | MICROSCAN MICROSTREP PLUS PANEL CEFUROXIME (0.12-8 MCG/ML) | Oct 26, 2006 | Substantially Equivalent | Dade Behring, Inc. |
| K062375 | MICROSCAN MICROSTREP PLUS PANEL ERYTHROMYCIN (0.015 TO 2 MCG/ML) | Oct 26, 2006 | Substantially Equivalent | Dade Behring, Inc. |
| K062923 | MICROSCAN MICROSTREP PLUS PANEL TETRACYCLINE (0.006 TO 16 MCG/ML) | Oct 13, 2006 | Substantially Equivalent | Dade Behring, Inc. |
| K062927 | MICROSCAN MICROSTREP PLUS PANEL AMPICILLIN (0.013 - 16 MCG/ML) | Oct 12, 2006 | Substantially Equivalent | Dade Behring, Inc. |
| K062596 | MICROSTREP PLUS PANEL AMOXICILLIN/CLAVULANIC ACID | Sep 19, 2006 | Substantially Equivalent | Dade Behring, Inc. |
| K062585 | MICROSCAN MICROSTREP PLUS PANEL AZITHROMYCIN | Sep 19, 2006 | Substantially Equivalent | Dade Behring, Inc. |
| K062290 | MICROSCAN MICROSTREP PLUS PANEL VANCOMYCIN (0.06 - 8 MCG/ML) | Sep 01, 2006 | Substantially Equivalent | Dade Behring, Inc. |
| K062293 | MICROSCAN MICROSTREP PLUS PANEL CHLORAMPHENICOL (1 TO 32 MCG/ML) | Aug 24, 2006 | Substantially Equivalent | Dade Behring, Inc. |
| K062276 | MICROSCAN MICROSTREP PLUS PANEL | Aug 23, 2006 | Substantially Equivalent | Dade Behring, Inc. |
| K062179 | MICROSCAN DRIED GRAM-POSITIVE MIC/COMBO PANELS WITH ERYTHROMYCIN (0.25 - 16UG/ML) | Aug 23, 2006 | Substantially Equivalent | Dade Behring, Inc. |
| K061872 | MICROSCAN MICROSTREP PLUS PANEL | Aug 23, 2006 | Substantially Equivalent | Dade Behring, Inc. |
| K053243 | SENSITITRE 18-24 HOURS SUSCEPTIBILITY PLATES | Jan 20, 2006 | Substantially Equivalent | Trek Diagnostic Systems, Inc. |
| K050043 | MICROSCAN DRIED GRAM-POSITIVE MIC/COMBO PANELS WITH ERYTHROMYCIN | Mar 29, 2005 | Substantially Equivalent | Dade Behring, Inc. |
| K050585 | MICROSCAN DRIED GRAM NEGATIVE MIC/COMBO PANELS AMOXICILLIN/K. CLAVULANATE | Mar 18, 2005 | Substantially Equivalent | Dade Behring, Inc. |
| K043545 | MICROSCAN DRIED GRAM-POSITIVE MIC/COMBO PANELS WITH DAPTOMYCIN (0.03 - 16 MCG/ML) | Feb 17, 2005 | Substantially Equivalent | Dade Behring, Inc. |
| K041150 | MICROSCAN SYNERGIES PLUS GRAM-NEGATIVE MIC/COMBO PANELS | Jul 22, 2004 | Substantially Equivalent | Dade Behring, Inc. |
| K033948 | MICROSCAN DRIED GRAM-NEGATIVE MIC/COMBO PANELS (GEMIFLOXACIN) | Mar 01, 2004 | Substantially Equivalent | Dade Behring, Inc. |
| K981199 | MICROSCAN DRIED GRAM NEGATIVE MIC/COMBO PANELS , ESBL SCREEN | Nov 18, 1998 | Substantially Equivalent | Dade Microscan, Inc. |
| K941425 | ALAMAR ANTIBIOTIC SUSCEPTIBILITY | Dec 15, 1994 | Substantially Equivalent | Alamar Biosciences Laboratory, Inc. |
| K930478 | READAR | Oct 22, 1993 | Substantially Equivalent | Alamar Biosciences, Inc. |
| K921977 | SYNERGY SCREEN TEST, MODIFICATION | Oct 12, 1993 | Substantially Equivalent | Baxter Healthcare Corp |
| K925951 | READAR | Aug 31, 1993 | Substantially Equivalent | Alamar Biosciences Laboratory, Inc. |
| K925859 | READAR/SUSCEPTIBILITY, GRAM NEGATIVE PANELS | Jul 08, 1993 | Substantially Equivalent | Alamar Biosciences, Inc. |
| K922482 | MICROSCAN DRI GRAM POSIT/GRAM NEGA MIC/COMBO PANEL | Mar 12, 1993 | Substantially Equivalent | Baxter Diagnostics, Inc. |
| K911419 | SENSITITRE ARIS MODULE | Jul 01, 1992 | Substantially Equivalent | Sensititre , Ltd. |
| K911400 | WALKAWAY TM 40 | Nov 19, 1991 | Substantially Equivalent | Baxter Healthcare Corp |
| K900821 | AUTOSCEPTOR-GRAM-POSITIVE MIC PANEL READING | Mar 15, 1990 | Substantially Equivalent | Bd Becton Dickinson Vacutainer Systems Preanalytic |
| K896447 | AUTOSCEPTOR | Jan 02, 1990 | Substantially Equivalent | Bd Becton Dickinson Vacutainer Systems Preanalytic |
| K883907 | SCEPTORPETTE SYSTEM | Oct 27, 1988 | Substantially Equivalent | Bd Becton Dickinson Vacutainer Systems Preanalytic |
| K865062 | ALADIN (TM) | Mar 25, 1987 | Substantially Equivalent | Analytical Products, Inc. |
FEI Numbers
This FDA classification entry is associated with 10 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 10 registration numbers. Click on an entry to view related FDA registrations.