510(k) K232643 ยท QWB Over-The-Counter Molecular Test To Detect Sars-Cov-2 From Clinical Specimens
Cue COVID-19 Molecular Test
| Applicant | Cue Health, Inc., San Diego CA, US |
| Decision | Substantially Equivalent, Nov 28, 2023 |
| Received | Aug 30, 2023 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K232643
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.