VRESELECT CULTURE MEDIUM
FDA 510(k) clearance K103684 · decided 2011-10-21
Clearance details
- K-number
- K103684
- Device name
- VRESELECT CULTURE MEDIUM
- Applicant
- Bio-Rad
- Decision
- Substantially Equivalent
- Date received
- 2010-12-17
- Decision date
- 2011-10-21
- Days to decision
- 308 days
- Clearance type
- Traditional
- Product code
- JSO
- Device class
- 2
- Regulation number
- 866.1700
- Medical specialty
- Microbiology
- Advisory committee
- Microbiology
- Location
- Beverly, MA, US
- Third-party review
- No
- Expedited review
- No
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| 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 |
| 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
No recalls on record reference this clearance.
PMA approvals by this applicant
| Record | Firm | Date |
|---|---|---|
| BIO-RAD CYCLOSPORINE BY HPLC TEST (P880032/S002) | Bio-Rad | 1996-03-01 |
| BIO-RAD CYCLOSPORINE BY HPLC TEST (P880032/S001) | Bio-Rad | 1991-03-14 |
| BIO-RAD CYCLOSPORINE BY HPLC TEST (P880032) | Bio-Rad | 1989-07-24 |