510(k) K102170 ยท OCC Respiratory Virus Panel Nucleic Acid Assay System
SIMPLEXA FLU A/B & RSV
| Applicant | Focus Diagnostics, Inc., Cypress CA, US |
| Decision | Substantially Equivalent, Nov 24, 2010 |
| Received | Aug 2, 2010 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K102170
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.