K243518
- 510(k) number
- K243518
- Device name
- BinaxNOW COVID-19 Antigen Self Test
- Applicant
- Abbott Diagnostics Scarborough, Inc. ME · US
- Product code
- QYT — Over-The-Counter Covid-19 Antigen Test
- Decision date
- 2025-02-11
- Date received
- 2024-11-13
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Microbiology
PDFDownload 510(k) SummaryArchived here · 2.6 MB · U.S. public domain
Also available from FDA: K243518.pdf
Official FDA record: K243518
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.