BinaxNOW COVID-19 Antigen Self Test— 510(k) K243518
Substantially EquivalentAbbott Diagnostics Scarborough, Inc.
FDA 510(k) clearance K243518 for BinaxNOW COVID-19 Antigen Self Test, Substantially Equivalent on 2025-02-11. Applicant: Abbott Diagnostics Scarborough, Inc.. Device class: 2.
Clearance details
- Applicant
- Abbott Diagnostics Scarborough, Inc.
- Product code
- Code QYT
- Device class
- Class 2
- Regulation
- 21 CFR 866.3984
- Advisory panel
- Microbiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Scarborough, ME, US
Recent devices under product code QYT
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