510(k) K171552 ยท OCC Respiratory Virus Panel Nucleic Acid Assay System
Xpert Xpress Flu, Xpert Nasopharyngeal Sample Collection Kit, Xpert Nasal Sample Collection Kit, GeneXpert Xpress II, GeneXpert Xpress IV
| Applicant | Cepheid, Sunnyvale CA, US |
| Decision | Substantially Equivalent, Dec 19, 2017 |
| Received | May 26, 2017 |
| Type | Dual Track |
| FDA record | Open on fda.gov |
Recalls that name K171552
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.