VIDAS B.R.A.H.M.S. PCT ASSAY
FDA 510(k) clearance K071146 · decided 2007-10-11
Clearance details
- K-number
- K071146
- Device name
- VIDAS B.R.A.H.M.S. PCT ASSAY
- Applicant
- bioMerieux, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2007-04-24
- Decision date
- 2007-10-11
- Days to decision
- 170 days
- Clearance type
- Traditional
- Product code
- NTM
- Device class
- 2
- Regulation number
- 866.3210
- Medical specialty
- Microbiology
- Advisory committee
- Microbiology
- Location
- Hazelwood, MO, 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.
| Record | Firm | Date |
|---|---|---|
| B R A H M S PCT SENSITIVE KRYPTOR TEST SYSTEM (K070310) | Brahms Aktiengesellschaft | 2008-03-31 |
| B-R-A-H-M-S PCT LIA (K040887) | Brahms Aktiengesellschaft | 2005-01-07 |
Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| VIDAS CLINICAL VIDAS BRAHMS PROCALCITONIN 60T, CATALOG 30450-01 recall (Z-0868-2023) | Biomerieux Inc | 2023-01-04 |
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 |