510(k) K212147 ยท QQX Respiratory Specimen Nucleic Acid Sars-Cov-2 Test
Simplexa COVID-19 Direct
| Applicant | Diasorin Molecular, LLC, Cypress CA, US |
| Decision | Substantially Equivalent, Sep 13, 2022 |
| Received | Jul 9, 2021 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K212147
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.