JSO · Culture Media, Antimicrobial Susceptibility Test, Excluding Mueller Hinton Agar
Microbiology · 21 CFR 866.1700 · Class 2
Overview
| Product Code | JSO |
|---|---|
| Device Name | Culture Media, Antimicrobial Susceptibility Test, Excluding Mueller Hinton Agar |
| Regulation | 21 CFR 866.1700 |
| Device Class | Class 2 |
| Review Panel | Microbiology |
| 3rd-Party Reviewable | Yes |
Identification
A culture medium for antimicrobial susceptibility tests is a device intended for medical purposes that consists of any medium capable of supporting the growth of many of the bacterial pathogens that are subject to antimicrobial susceptibility tests. The medium should be free of components known to be antagonistic to the common agents for which susceptibility tests are performed in the treatment of disease.
Classification Rationale
Class II (performance standards).
Recent Cleared Devices (20 of 40)
Showing 20 most recent of 40 cleared devices.
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K190553 | HardyCHROM CRE | Hardy Diagnostics | Apr 29, 2019 | SESE |
| K181092 | CHROMID CARBA agar (CARB) | Biomerieux S.A. | Jul 6, 2018 | SESE |
| K171061 | MRSASelect II | Bio-Rad | Dec 28, 2017 | SESE |
| K162620 | Remel Spectra ESBL | Remel, Inc. | May 1, 2017 | SESE |
| K160512 | HardyCHROM ESBL | Hardy Diagnostics | Nov 15, 2016 | SESE |
| K162076 | chromID MRSA | bioMerieux, Inc. | Oct 25, 2016 | SESE |
| K151688 | chromID MRSA | bioMerieux, Inc. | Mar 11, 2016 | SESE |
| K122187 | VRESELECT CULTURE MEDIUM | Bio-Rad | Nov 6, 2012 | SESE |
| K103684 | VRESELECT CULTURE MEDIUM | Bio-Rad | Oct 21, 2011 | SESE |
| K102922 | HARDYCHROM MRSA | Hardy Diagnostics | May 4, 2011 | SESE |
| K100589 | MRSA SELECT - SKIN AND SOFT TISSUE WOUND SPECIMENS | Bio-Rad | Oct 29, 2010 | SESE |
| K092407 | REMEL SPECTRA MRSA | Remel, Inc. | Oct 8, 2010 | SESE |
| K092767 | BBL CHROMAGAR MRSA II | Becton, Dickinson & CO | Aug 20, 2010 | SESE |
| K092819 | REMEL SPECTRA VRE | Thermo Fisher Scientific | Jul 15, 2010 | SESE |
| K091025 | CHROMID VRE AGAR, MODEL: REF 43 851 | bioMerieux, Inc. | Mar 2, 2010 | SESE |
| K091024 | CHROMID MRSA AGAR, MODEL: REF 43 841 | bioMerieux, Inc. | Jul 17, 2009 | SESE |
| K081212 | MRSASELECT - EXTENDED INCUBATION | Bio-Rad | Jun 13, 2008 | SESE |
| K073027 | SPECTRA MRSA | Thermo Fisher Scientific | Feb 28, 2008 | SESE |
| K070361 | MRSASELECT | Bio-Rad | Sep 13, 2007 | SESE |
| K042812 | BBLCHROMAGAR MRSA | Becton, Dickinson & CO | Nov 22, 2004 | SESE |
Top Applicants
- Bio-Rad — 6 clearances
- Hardy Diagnostics — 5 clearances
- bioMerieux, Inc. — 4 clearances
- Remel Co. — 3 clearances
- Becton Dickinson Microbiology Systems — 3 clearances
