Product code JSO
- Device name
- Culture Media, Antimicrobial Susceptibility Test, Excluding Mueller Hinton Agar
- Medical specialty
- Microbiology
- Device class
- 2
- Regulation number
- 866.1700
- Review panel
- MI
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- Y
- Summary malfunction reporting
- Eligible
- Source
- FDA openFDA device classification dataset
Related 510(k) Records#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K190553 | HardyCHROM CRE | Hardy Diagnostics | 2019-04-29 |
| K181092 | CHROMID CARBA agar (CARB) | Biomerieux S.A. | 2018-07-06 |
| K171061 | MRSASelect II | Bio-Rad | 2017-12-28 |
| K162620 | Remel Spectra ESBL | Remel, Inc. | 2017-05-01 |
| K160512 | HardyCHROM ESBL | Hardy Diagnostics | 2016-11-15 |
| K162076 | chromID MRSA | bioMerieux, Inc. | 2016-10-25 |
| K151688 | chromID MRSA | bioMerieux, Inc. | 2016-03-11 |
| K122187 | VRESELECT CULTURE MEDIUM | Bio-Rad | 2012-11-06 |
| K103684 | VRESELECT CULTURE MEDIUM | Bio-Rad | 2011-10-21 |
| K102922 | HARDYCHROM MRSA | Hardy Diagnostics | 2011-05-04 |
| K100589 | MRSA SELECT - SKIN AND SOFT TISSUE WOUND SPECIMENS | Bio-Rad | 2010-10-29 |
| K092407 | REMEL SPECTRA MRSA | Remel, Inc. | 2010-10-08 |
| K092767 | BBL CHROMAGAR MRSA II | Becton, Dickinson & CO | 2010-08-20 |
| K092819 | REMEL SPECTRA VRE | Thermo Fisher Scientific | 2010-07-15 |
| K091025 | CHROMID VRE AGAR, MODEL: REF 43 851 | bioMerieux, Inc. | 2010-03-02 |
| K091024 | CHROMID MRSA AGAR, MODEL: REF 43 841 | bioMerieux, Inc. | 2009-07-17 |
| K081212 | MRSASELECT - EXTENDED INCUBATION | Bio-Rad | 2008-06-13 |
| K073027 | SPECTRA MRSA | Thermo Fisher Scientific | 2008-02-28 |
| K070361 | MRSASELECT | Bio-Rad | 2007-09-13 |
| K042812 | BBLCHROMAGAR MRSA | Becton, Dickinson & CO | 2004-11-22 |
| K972359 | REMEL BILE ESCULIN AZIDE AGAR W/6 MCG/ML VANCOMYCIN | Remel, L.P. | 1997-08-28 |
| K964560 | BHI W/VANCOMYCIN AGAR | Hardy Diagnostics | 1997-01-15 |
| K962744 | HAEMOPHILUS TEST MEDIUM AGAR (HTM) | Prepared Media Laboratory, Inc. | 1996-10-15 |
| K952595 | HAEMOPHILUS TEST MEDIUM (HTM) | Clinical Standards Laboratories, Inc. | 1996-04-10 |
| K951754 | CULTURE MEDIA, ANTIMICROBIAL SUSCEPTIBILITY TEST | Hardy Diagnostics | 1995-10-16 |
| K945569 | GCII AGAR WITH ISOVITALX(R) ENRICHMENT | Becton Dickinson Microbiology Systems | 1995-02-02 |
| K944554 | BRAIN HEART INFUSION AGAR | Carr-Scarborough Microbiologicals, Inc. | 1994-10-04 |
| K941443 | SYNERGY QUAD | Remel Co. | 1994-09-19 |
| K941444 | BHI AGAR WITH VANCOMYCIN | Remel Co. | 1994-09-19 |
| K932882 | GC II AGAR WITH ISOVITALEX | Becton Dickinson Microbiology Systems | 1993-09-24 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 30382902154212 | BD BBL™ CHROMagar™ MRSA II / CHROMagar™ SA | BECTON, DICKINSON AND COMPANY | 2024-08-22 |
| 10382902154218 | BD BBL™ CHROMagar™ MRSA II / CHROMagar™ SA | BECTON, DICKINSON AND COMPANY | 2024-08-22 |
| 00816576026838 | HardyCHROM™ | HARDY DIAGNOSTICS | 2023-12-08 |
| 00816576026845 | HardyCHROM™ | HARDY DIAGNOSTICS | 2023-12-08 |
| 00848838085635 | SPECTRA | REMEL, INC. | 2022-12-22 |
| 00848838085628 | SPECTRA | REMEL, INC. | 2022-12-22 |
| 00816576026807 | HardyCHROM | HARDY DIAGNOSTICS | 2020-05-20 |
| 00816576025770 | HardyCHROM™ | HARDY DIAGNOSTICS | 2019-10-21 |
| 03573026409913 | CHROMID® CARBA agar | BIOMERIEUX SA | 2018-09-28 |
| 03573026597719 | CHROMID® CARBA agar | BIOMERIEUX SA | 2018-09-28 |
| 03610521536208 | Select | BIO-RAD | 2018-02-09 |
| 03610521536215 | Select | BIO-RAD | 2018-02-09 |
| 30382902152287 | BD BBL™ CHROMagar® MRSA II | BECTON, DICKINSON AND COMPANY | 2016-12-23 |
| 10382902152283 | BD BBL™ CHROMagar® MRSA II | BECTON, DICKINSON AND COMPANY | 2016-12-23 |
| 30382902219546 | BD BBL™ Haemophilus Test Medium Agar (HTM Agar) | BECTON, DICKINSON AND COMPANY | 2016-12-21 |
| 10382902152290 | BD BBL™ CHROMagar® MRSA II | BECTON, DICKINSON AND COMPANY | 2016-12-21 |
| 30382902152294 | BD BBL™ CHROMagar® MRSA II | BECTON, DICKINSON AND COMPANY | 2016-12-21 |
| 30382902212400 | BD BBL™ GC II Agar with IsoVitaleX™ Enrichment | BECTON, DICKINSON AND COMPANY | 2016-12-21 |
| 10382902219542 | BD BBL™ Haemophilus Test Medium Agar (HTM Agar) | BECTON, DICKINSON AND COMPANY | 2016-12-21 |
| 10382902212406 | BD BBL™ GC II Agar with IsoVitaleX™ Enrichment | BECTON, DICKINSON AND COMPANY | 2016-12-21 |
| 30382902153598 | BD BBL™ CHROMagar™ MRSA II / CHROMagar™ SA | BECTON, DICKINSON AND COMPANY | 2016-12-16 |
| 10382902153594 | BD BBL™ CHROMagar™ MRSA II / CHROMagar™ SA | BECTON, DICKINSON AND COMPANY | 2016-12-16 |
| 03573026552138 | CHROMID® VRE Agar | BIOMERIEUX SA | 2016-09-23 |
| 03573026552114 | CHROMID® MRSA agar | BIOMERIEUX SA | 2016-09-23 |
| 03573026313111 | CHROMID® MRSA agar | BIOMERIEUX SA | 2016-09-23 |
| 03573026313128 | CHROMID® VRE Agar | BIOMERIEUX SA | 2016-09-23 |
| 03573026552091 | CHROMID® MRSA / CHROMID S. aureus | BIOMERIEUX SA | 2016-09-16 |
| 03573026420758 | chromID™ MRSA /SAID | BIOMERIEUX SA | 2016-09-16 |
| 03610520002971 | Select | BIO-RAD | 2016-08-16 |
| 03610520002933 | Select | BIO-RAD | 2016-08-16 |