510(k) K261837 ยท QOF Multi-Target Respiratory Specimen Nucleic Acid Test Including Sars-Cov-2 And Other Microbial Agents
FINDER Flu A&B/SARS-CoV-2 Test
| Applicant | Baebies, Inc., Durham NC, US |
| Decision | Substantially Equivalent, Sep 11, 2026 |
| Received | Jun 2, 2026 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K261837
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.