BACT/ALERT FA CULTURE BOTTLE
FDA 510(k) clearance K020813 · decided 2002-04-17
Clearance details
- K-number
- K020813
- Device name
- BACT/ALERT FA CULTURE BOTTLE
- Applicant
- bioMerieux, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2002-03-13
- Decision date
- 2002-04-17
- Days to decision
- 35 days
- Clearance type
- Traditional
- Product code
- MDB
- Device class
- 1
- Regulation number
- 866.2560
- Medical specialty
- Microbiology
- Advisory committee
- Microbiology
- Location
- Durham, NC, US
- Third-party review
- No
- Expedited review
- No
+ Add to Predicate Builder ◉ Watch bioMerieux
Need this as data, not a web page?
Query all 176,000+ clearances through the Atlas FDA API, or subscribe to weekly change alerts. Self-serve from $29/mo.
Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| BacT/ALERT - FA Reagent Bottle The BacT/ALERT Microbial Detection System is used to determ recall (Z-2244-2011) | bioMerieux, Inc. | 2011-05-24 |
| BacT/ALERT FA Culture Bottles, 30 ml, for in vitro diagnostic use, BioMerieux, Inc., Durha recall (Z-0643-2007) | bioMerieux, Inc. | 2007-03-22 |
PMA approvals by this applicant
| Record | Firm | Date |
|---|---|---|
| THXID-BRAF (P120014/S012) | bioMerieux, Inc. | 2021-12-20 |
| THxID-BRAF kit (P120014/S011) | bioMerieux, Inc. | 2021-03-10 |
| THxID-BRAF assay kit (P120014/S010) | bioMerieux, Inc. | 2020-02-26 |
| THxID BRAF assay kit (P120014/S009) | bioMerieux, Inc. | 2019-08-26 |
| THxID BRAF assay kit (P120014/S008) | bioMerieux, Inc. | 2018-06-27 |
| THxID-BRAF kit (P120014/S007) | bioMerieux, Inc. | 2016-11-22 |
| VIDAS TOTAL PSA (P040008/S013) | bioMerieux, Inc. | 2016-05-31 |
| THXID-BRAF KIT (P120014/S006) | bioMerieux, Inc. | 2016-04-05 |