510(k) K253453 ยท QWB Over-The-Counter Molecular Test To Detect Sars-Cov-2 From Clinical Specimens
Metrix COVID Test; Metrix COVID Test Pro
| Applicant | Aptitude Medical Systems, Inc., Goleta CA, US |
| Decision | Substantially Equivalent, Aug 7, 2026 |
| Received | Oct 6, 2025 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K253453
No recall in the FDA data names this 510(k).
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.