K250273
- 510(k) number
- K250273
- Device name
- BinaxNOW COVID-19 Ag Card
- Applicant
- Abbott Diagnostics Scarborough, Inc. ME · US
- Product code
- QVF — Simple Point-Of-Care Device To Directly Detect Sars-
- Decision date
- 2025-06-13
- Date received
- 2025-01-30
- Decision
- Substantially Equivalent
- Clearance type
- Dual Track
- Advisory committee
- Microbiology
PDFDownload 510(k) SummaryArchived here · 2.6 MB · U.S. public domain
Also available from FDA: K250273.pdf
Official FDA record: K250273
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.