K232669
- 510(k) number
- K232669
- Device name
- TBI
- Applicant
- Abbott Laboratories IL · US
- Product code
- QAT — Brain Trauma Assessment Test
- Decision date
- 2023-09-29
- Date received
- 2023-09-01
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Advisory committee
- Immunology
PDFDownload 510(k) SummaryArchived here · 0.4 MB · U.S. public domain
Also available from FDA: K232669.pdf
Official FDA record: K232669
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.