510(k) K181289 ยท OCC Respiratory Virus Panel Nucleic Acid Assay System
Xpert Xpress Flu, Xpert Nasopharyngeal Sample Collection Kit, Xpert Nasal Sample Collection Kit, GeneXpert Dx Systems (GX-I, GX-II, GX-IV, GX-XVI), GeneXpert Infinity-48S System and GeneXpert Infinity-80 System
| Applicant | Cepheid, Sunnyvale CA, US |
| Decision | Substantially Equivalent, Aug 15, 2018 |
| Received | May 16, 2018 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K181289
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.