K233688
- 510(k) number
- K233688
- Device name
- Sofia 2 SARS Antigen+ FIA; Sofia 2 SARS Antigen+ FIA Control Swab Set
- Applicant
- Quidel Corporation CA · US
- Product code
- QVF — Simple Point-Of-Care Device To Directly Detect Sars-
- Decision date
- 2023-12-13
- Date received
- 2023-11-17
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Advisory committee
- Microbiology
PDFDownload 510(k) SummaryArchived here · 0.4 MB · U.S. public domain
Also available from FDA: K233688.pdf
Official FDA record: K233688
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.