510(k) K220963 ยท QOF Multi-Target Respiratory Specimen Nucleic Acid Test Including Sars-Cov-2 And Other Microbial Agents
Simplexa COVID-19 & Flu A/B Direct
| Applicant | Diasorin Molecular, LLC, Cypress CA, US |
| Decision | Substantially Equivalent, Mar 17, 2023 |
| Received | Apr 1, 2022 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K220963
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.