510(k) K153544 ยท OCC Respiratory Virus Panel Nucleic Acid Assay System
cobas Influenza A/B & RSV Nucleic Acid Test for Use on the cobas Liat System
| Applicant | Iquum, Inc., Marlborough MA, US |
| Decision | Substantially Equivalent, Jul 25, 2016 |
| Received | Dec 11, 2015 |
| Type | Dual Track |
| FDA record | Open on fda.gov |
Recalls that name K153544
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.