510(k) K151226 ยท OCC Respiratory Virus Panel Nucleic Acid Assay System
Xpert Flu+RSV Xpress, Xpert Nasopharyngeal Sample Collection Kit, GeneXpert Xpress System (GX-I)
| Applicant | Cepheid, Sunnyvale CA, US |
| Decision | Substantially Equivalent, Dec 3, 2015 |
| Received | May 7, 2015 |
| Type | Dual Track |
| FDA record | Open on fda.gov |
Recalls that name K151226
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.