HardyCHROM CRE
FDA 510(k) clearance K190553 · decided 2019-04-29
Clearance details
- K-number
- K190553
- Device name
- HardyCHROM CRE
- Applicant
- Hardy Diagnostics
- Decision
- Substantially Equivalent
- Date received
- 2019-03-05
- Decision date
- 2019-04-29
- Days to decision
- 55 days
- Clearance type
- Traditional
- Product code
- JSO
- Device class
- 2
- Regulation number
- 866.1700
- Medical specialty
- Microbiology
- Advisory committee
- Microbiology
- Location
- Santa Maria, CA, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| CHROMID CARBA agar (CARB) (K181092) | Biomerieux S.A. | 2018-07-06 |
| MRSASelect II (K171061) | Bio-Rad | 2017-12-28 |
| Remel Spectra ESBL (K162620) | Remel, Inc. | 2017-05-01 |
| HardyCHROM ESBL (K160512) | Hardy Diagnostics | 2016-11-15 |
| chromID MRSA (K162076) | bioMerieux, Inc. | 2016-10-25 |
| chromID MRSA (K151688) | bioMerieux, Inc. | 2016-03-11 |
| VRESELECT CULTURE MEDIUM (K122187) | Bio-Rad | 2012-11-06 |
| VRESELECT CULTURE MEDIUM (K103684) | Bio-Rad | 2011-10-21 |
| HARDYCHROM MRSA (K102922) | Hardy Diagnostics | 2011-05-04 |
| MRSA SELECT - SKIN AND SOFT TISSUE WOUND SPECIMENS (K100589) | Bio-Rad | 2010-10-29 |
| REMEL SPECTRA MRSA (K092407) | Remel, Inc. | 2010-10-08 |
| BBL CHROMAGAR MRSA II (K092767) | Becton, Dickinson & CO | 2010-08-20 |
Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| HardyCHROM CRE, selective and differential culture medium for antimicrobial susceptibility recall (Z-2041-2025) | Hardy Diagnostics | 2025-06-27 |