K234143
- 510(k) number
- K234143
- Device name
- i-STAT TBI Cartridge with the i-STAT Alinity System
- Applicant
- Abbott Point of Care NJ · US
- Product code
- QAT — Brain Trauma Assessment Test
- Decision date
- 2024-03-27
- Date received
- 2023-12-29
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Immunology
PDFDownload 510(k) SummaryArchived here · 1.0 MB · U.S. public domain
Also available from FDA: K234143.pdf
Official FDA record: K234143
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.