K253453
- 510(k) number
- K253453
- Device name
- Metrix COVID Test; Metrix COVID Test Pro
- Applicant
- Aptitude Medical Systems, Inc. CA · US
- Product code
- QWB — Over-The-Counter Molecular Test To Detect Sars-Cov-2
- Decision date
- 2026-08-07
- Date received
- 2025-10-06
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Microbiology
PDFDownload 510(k) SummaryArchived here · 2.7 MB · U.S. public domain
Also available from FDA: K253453.pdf
Official FDA record: K253453
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.