510(k) K142365 ยท OCC Respiratory Virus Panel Nucleic Acid Assay System
Simplexa Flu A/B & RSV Direct & Simplexa Flu A/B RSV Positive Control Pack
| Applicant | Focus Diagnostics, Cypress CA, US |
| Decision | Substantially Equivalent, Dec 5, 2014 |
| Received | Aug 25, 2014 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K142365
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.