510(k) K152408 ยท OCC Respiratory Virus Panel Nucleic Acid Assay System
Simplexa Flu A/B & RSV Direct and Simplexa Flu A/B & RSV Positive Control Pack
| Applicant | Focus Diagnostics, Inc., Cypress CA, US |
| Decision | Substantially Equivalent, Sep 21, 2015 |
| Received | Aug 25, 2015 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K152408
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Apr 2, 2016 | Focus Diagnostics Inc Simplexa Flu A/B & RSV Direct (MOL2650) with Direct Amplification Disc (MOL1451, MOL1452, MOL1455)
Model Number: MOL2650, MOL1451, MOL1452, MOL1455 Terminated |
OCC | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.