Panels › Immunology › Product code QAT · Class 2
Brain Trauma Assessment Test
Regulation 866.5830
0510(k)s in 12 months (6 all time)
0recalls in 12 months (0 all time)
0recalls that name a 510(k)
Top companies in QAT
| Company | 510(k)s | Recalls |
|---|---|---|
| Abbott Laboratories | 3 | 0 |
| Abbott Point of Care | 1 | 0 |
| Banyan Biomarkers, Inc. | 1 | 0 |
| bioMerieux, Inc. | 1 | 0 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| May 1, 2024 | K240279 | VIDAS TBI (GFAP, UCH-L1) bioMerieux, Inc. | QAT |
| Mar 27, 2024 | K234143 | i-STAT TBI Cartridge with the i-STAT Alinity System Abbott Point of Care | QAT |
| Sep 29, 2023 | K232669 | TBI Abbott Laboratories | QAT |
| Mar 2, 2023 | K223602 | Traumatic brain injury (TBI) test Abbott Laboratories | QAT |
| Jan 8, 2021 | K201778 | i-STAT TBI Plasma cartridge with the i-STAT Alinity System Abbott Laboratories | QAT |
| Feb 14, 2018 | DEN170045 | Banyan BTI Banyan Biomarkers, Inc. | QAT |
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