510(k) K241580 ยท QQX Respiratory Specimen Nucleic Acid Sars-Cov-2 Test
Alinity m SARS-CoV-2 AMP Kit (09N78-096); Alinity m SARS-CoV-2 CTRL Kit (09N78-086)
| Applicant | Abbott Molecular, Des Plaines IL, US |
| Decision | Substantially Equivalent, Dec 6, 2024 |
| Received | Jun 3, 2024 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K241580
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.