510(k) K243518
K243518 is an FDA 510(k) premarket notification submitted by Abbott Diagnostics Scarborough, Inc. for the device "BinaxNOW COVID-19 Antigen Self Test". The FDA issued a decision of Substantially Equivalent on February 11, 2025. The device falls under product code QYT (Over-The-Counter Covid-19 Antigen Test), a Class II device regulated under 21 CFR 866.3984. Abbott Diagnostics Scarborough, Inc. has at least 5 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- February 11, 2025
- Date Received
- November 13, 2024
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Over-The-Counter Covid-19 Antigen Test
- Device Class
- Class II
- Regulation Number
- 866.3984
- Review Panel
- MI
- Submission Type
For the rapid, qualitative detection of SARS-CoV-2 virus nucleocapsid protein antigen in individuals 2 years and older.