K240279
- 510(k) number
- K240279
- Device name
- VIDAS TBI (GFAP, UCH-L1)
- Applicant
- bioMerieux, Inc. MO · US
- Product code
- QAT — Brain Trauma Assessment Test
- Decision date
- 2024-05-01
- Date received
- 2024-02-01
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Immunology
PDFDownload 510(k) SummaryArchived here · 2.6 MB · U.S. public domain
Also available from FDA: K240279.pdf
Official FDA record: K240279
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.