510(k) K223602
- Device
- Traumatic brain injury (TBI) test
- Applicant
- Abbott Laboratories
- 510(k) number
- K223602
- Product code
- QAT
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2023-03-02
- Date received
- 2022-12-02
- Regulation
- 866.5830
- Classification name
- Brain Trauma Assessment Test
- Medical specialty
- Immunology
- Review panel
- Immunology
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- Lisa Kelly
- Address
- 100 Abbott Park Rd. Abbott Park IL US 60064 60064
FDA Registration Numbers#
- 2085064
- 3002809144
- 8020790
- 2032839
- 2245578
- 3008344661
- 3005333358
- 2953756
- 3005643513
Source Documents#
Other 510(k) Records For Product Code QAT#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K240279 | VIDAS TBI (GFAP, UCH-L1) | bioMerieux, Inc. | 2024-05-01 |
| K234143 | i-STAT TBI Cartridge with the i-STAT Alinity System | Abbott Point of Care | 2024-03-27 |
| K232669 | TBI | Abbott Laboratories | 2023-09-29 |
| K201778 | i-STAT TBI Plasma cartridge with the i-STAT Alinity System | Abbott Laboratories | 2021-01-08 |
| DEN170045 | Banyan BTI | Banyan Biomarkers, Inc. | 2018-02-14 |