VIDAS TBI (GFAP, UCH-L1)
FDA 510(k) clearance K240279 · decided 2024-05-01
Clearance details
- K-number
- K240279
- Device name
- VIDAS TBI (GFAP, UCH-L1)
- Applicant
- bioMerieux, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2024-02-01
- Decision date
- 2024-05-01
- Days to decision
- 90 days
- Clearance type
- Traditional
- Product code
- QAT
- Device class
- 2
- Regulation number
- 866.5830
- Medical specialty
- Immunology
- Advisory committee
- Immunology
- 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 |
|---|---|---|
| i-STAT TBI Cartridge with the i-STAT Alinity System (K234143) | Abbott Point of Care | 2024-03-27 |
| TBI (K232669) | Abbott Laboratories | 2023-09-29 |
| Traumatic brain injury (TBI) test (K223602) | Abbott Laboratories | 2023-03-02 |
| i-STAT TBI Plasma cartridge with the i-STAT Alinity System (K201778) | Abbott Laboratories | 2021-01-08 |
| Banyan BTI (DEN170045) | Banyan Biomarkers, Inc. | 2018-02-14 |
Recalls involving this device
No recalls on record reference this clearance.
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 |