BinaxNOW COVID-19 Ag Card— 510(k) K250273
Substantially EquivalentAbbott Diagnostics Scarborough, Inc.
FDA 510(k) clearance K250273 for BinaxNOW COVID-19 Ag Card, Substantially Equivalent on 2025-06-13. Applicant: Abbott Diagnostics Scarborough, Inc.. Device class: 2.
Clearance details
- Applicant
- Abbott Diagnostics Scarborough, Inc.
- Product code
- Code QVF
- Device class
- Class 2
- Regulation
- 21 CFR 866.3982
- Advisory panel
- Microbiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Dual Track
- Location
- Scarborough, ME, US
Recent devices under product code QVF
view allMore clearances from Abbott Diagnostics Scarborough, Inc.
view allData sourced from openFDA. This site is unofficial and independent of the FDA.