Culture Media, Antimicrobial Susceptibility Test, Excluding Mueller Hinton Agar
Culture Media, Antimicrobial Susceptibility Test (excluding Mueller Hinton Agar) is a laboratory culture medium used to evaluate the sensitivity or resistance of isolated microorganisms to various antimicrobial agents, supporting appropriate antibiotic selection in clinical care. It is classified as FDA Class 2, indicating moderate risk and requiring 510(k) premarket notification to demonstrate substantial equivalence to a legally marketed predicate device. The product code is JSO, regulated under 21 CFR 866.1700, and falls within the Microbiology medical specialty. This device is eligible for third-party review.
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Basic Information
- Product Code
- JSO
- Device Class
- FDA class 2
- Regulation Number
- 866.1700
- Medical Specialty
- Microbiology
- Review Panel
- MI
- Submission Type
- 1
Device Characteristics
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 40 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K190553 | HardyCHROM CRE | Apr 29, 2019 | Substantially Equivalent | Hardy Diagnostics |
| K181092 | CHROMID CARBA agar (CARB) | Jul 06, 2018 | Substantially Equivalent | Biomerieux S.A. |
| K171061 | MRSASelect II | Dec 28, 2017 | Substantially Equivalent | Bio-Rad |
| K162620 | Remel Spectra ESBL | May 01, 2017 | Substantially Equivalent | Remel, Inc. |
| K160512 | HardyCHROM ESBL | Nov 15, 2016 | Substantially Equivalent | Hardy Diagnostics |
| K162076 | chromID MRSA | Oct 25, 2016 | Substantially Equivalent | bioMerieux, Inc. |
| K151688 | chromID MRSA | Mar 11, 2016 | Substantially Equivalent | bioMerieux, Inc. |
| K122187 | VRESELECT CULTURE MEDIUM | Nov 06, 2012 | Substantially Equivalent | Bio-Rad |
| K103684 | VRESELECT CULTURE MEDIUM | Oct 21, 2011 | Substantially Equivalent | Bio-Rad |
| K102922 | HARDYCHROM MRSA | May 04, 2011 | Substantially Equivalent | Hardy Diagnostics |
| K100589 | MRSA SELECT - SKIN AND SOFT TISSUE WOUND SPECIMENS | Oct 29, 2010 | Substantially Equivalent | Bio-Rad |
| K092407 | REMEL SPECTRA MRSA | Oct 08, 2010 | Substantially Equivalent | Remel, Inc. |
| K092767 | BBL CHROMAGAR MRSA II | Aug 20, 2010 | Substantially Equivalent | Becton, Dickinson & CO |
| K092819 | REMEL SPECTRA VRE | Jul 15, 2010 | Substantially Equivalent | Thermo Fisher Scientific |
| K091025 | CHROMID VRE AGAR, MODEL: REF 43 851 | Mar 02, 2010 | Substantially Equivalent | bioMerieux, Inc. |
| K091024 | CHROMID MRSA AGAR, MODEL: REF 43 841 | Jul 17, 2009 | Substantially Equivalent | bioMerieux, Inc. |
| K081212 | MRSASELECT - EXTENDED INCUBATION | Jun 13, 2008 | Substantially Equivalent | Bio-Rad |
| K073027 | SPECTRA MRSA | Feb 28, 2008 | Substantially Equivalent | Thermo Fisher Scientific |
| K070361 | MRSASELECT | Sep 13, 2007 | Substantially Equivalent | Bio-Rad |
| K042812 | BBLCHROMAGAR MRSA | Nov 22, 2004 | Substantially Equivalent | Becton, Dickinson & CO |
| K972359 | REMEL BILE ESCULIN AZIDE AGAR W/6 MCG/ML VANCOMYCIN | Aug 28, 1997 | Substantially Equivalent | Remel, L.P. |
| K964560 | BHI W/VANCOMYCIN AGAR | Jan 15, 1997 | Substantially Equivalent | Hardy Diagnostics |
| K962744 | HAEMOPHILUS TEST MEDIUM AGAR (HTM) | Oct 15, 1996 | Substantially Equivalent | Prepared Media Laboratory, Inc. |
| K952595 | HAEMOPHILUS TEST MEDIUM (HTM) | Apr 10, 1996 | Substantially Equivalent | Clinical Standards Laboratories, Inc. |
| K951754 | CULTURE MEDIA, ANTIMICROBIAL SUSCEPTIBILITY TEST | Oct 16, 1995 | Substantially Equivalent | Hardy Diagnostics |
| K945569 | GCII AGAR WITH ISOVITALX(R) ENRICHMENT | Feb 02, 1995 | Substantially Equivalent | Becton Dickinson Microbiology Systems |
| K944554 | BRAIN HEART INFUSION AGAR | Oct 04, 1994 | Substantially Equivalent | Carr-Scarborough Microbiologicals, Inc. |
| K941444 | BHI AGAR WITH VANCOMYCIN | Sep 19, 1994 | Substantially Equivalent | Remel Co. |
| K941443 | SYNERGY QUAD | Sep 19, 1994 | Substantially Equivalent | Remel Co. |
| K932882 | GC II AGAR WITH ISOVITALEX | Sep 24, 1993 | Substantially Equivalent | Becton Dickinson Microbiology Systems |
| K932879 | G C II AGAR WITH SENSIVITALEX | Sep 21, 1993 | Substantially Equivalent | Becton Dickinson Microbiology Systems |
| K923892 | SMITH RIVER MICROBIOLOGICAL CULTURE MEDIA | Jun 21, 1993 | Substantially Equivalent | Smith River Biologicals |
| K903425 | HAEMOPHILUS TEST MEDIUM (HTM) BROTH | Aug 22, 1990 | Substantially Equivalent | Bd Becton Dickinson Vacutainer Systems Preanalytic |
| K894216 | HAEMOPHILUS TEST MEDIUM (HTM)AGAR | Dec 13, 1989 | Substantially Equivalent | Bd Becton Dickinson Vacutainer Systems Preanalytic |
| K894848 | HAEMOPHILUS TEST MEDIUM (BROTH) | Sep 06, 1989 | Substantially Equivalent | Regional Media Laboratories |
| K892928 | HAEMOPHILUS TEST MEDIUM (AGAR) | Jun 13, 1989 | Substantially Equivalent | Remel Co. |
| K881568 | WILKENS CHALGREN BROTH | Apr 18, 1988 | Substantially Equivalent | Acumedia Manufacturers, Inc. |
| K881567 | WILKENS CHALGREN AGAR | Apr 18, 1988 | Substantially Equivalent | Acumedia Manufacturers, Inc. |
| K811513 | WILKINS-CHALGREN ANAEROBE AGAR | Jun 18, 1981 | Substantially Equivalent | Oxoid U.S.A., Inc. |
| K770441 | GAR, COLUMBIA, W/5% HORSE BLOOD | Mar 10, 1977 | Substantially Equivalent | Bd Becton Dickinson Vacutainer Systems Preanalytic |
FEI Numbers
This FDA classification entry is associated with 11 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 11 registration numbers. Click on an entry to view related FDA registrations.