K233606
- 510(k) number
- K233606
- Device name
- ADVIA Centaur EBV-VCA IgM
- Applicant
- Biokit, S.A. ES
- Product code
- LSE — Epstein-Barr Virus, Other
- Decision date
- 2024-08-07
- Date received
- 2023-11-09
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Microbiology
PDFDownload 510(k) SummaryArchived here · 0.9 MB · U.S. public domain
Also available from FDA: K233606.pdf
Official FDA record: K233606
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.