MRSASELECT
FDA 510(k) clearance K070361 · decided 2007-09-13
Clearance details
- K-number
- K070361
- Device name
- MRSASELECT
- Applicant
- Bio-Rad
- Decision
- Substantially Equivalent
- Date received
- 2007-02-07
- Decision date
- 2007-09-13
- Days to decision
- 218 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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| HardyCHROM CRE (K190553) | Hardy Diagnostics | 2019-04-29 |
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| 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 |
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 |