510(k) K201505 ยท OCC Respiratory Virus Panel Nucleic Acid Assay System
Simplexa Flu A/B & RSV Direct Gen II, Simplexa Flu A/B & RSV Positive Control Pack
| Applicant | Diasorin Molecular, LLC, Cypress CA, US |
| Decision | Substantially Equivalent, Aug 22, 2020 |
| Received | Jun 5, 2020 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K201505
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Mar 3, 2023 | DiaSorin Molecular LLC Simplexa Flu A/B & RSV Direct Gen II, REF: MOL2655; including Reaction Mix REF: MOL2656; with previous assay definition v5. Open, Classified |
OCC | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.