510(k) K180218 ยท OCC Respiratory Virus Panel Nucleic Acid Assay System
Xpert Xpress Flu/RSV, Xpert Nasopharyngeal Sample Collection Kit, Xpert Nasal Sample Collection Kit, GeneXpert Xpress II, GeneXpert Xpress IV
| Applicant | Cepheid, Sunnyvale CA, US |
| Decision | Substantially Equivalent, Jul 24, 2018 |
| Received | Jan 25, 2018 |
| Type | Dual Track |
| FDA record | Open on fda.gov |
Recalls that name K180218
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.