FDA Product Code
FDA Product Code QAT — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Immunology
- 21 CFR Citation
- 866.5830
510(k) Clearances — 6 records
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K240279 | VIDAS TBI (GFAP, UCH-L1) | bioMerieux, Inc. | 2024-05-01 | Traditional | PDF ↗ |
| K234143 | i-STAT TBI Cartridge with the i-STAT Alinity System | Abbott Point of Care | 2024-03-27 | Traditional | PDF ↗ |
| K232669 | TBI | Abbott Laboratories | 2023-09-29 | Special | PDF ↗ |
| K223602 | Traumatic brain injury (TBI) test | Abbott Laboratories | 2023-03-02 | Traditional | PDF ↗ |
| K201778 | i-STAT TBI Plasma cartridge with the i-STAT Alinity System | Abbott Laboratories | 2021-01-08 | Traditional | PDF ↗ |
| DEN170045 | Banyan BTI | Banyan Biomarkers, Inc. | 2018-02-14 | Direct | — |
Product code QAT · Class II · Immunology. Data: openFDA.