510(k) K142501 ยท PCH Gastrointestinal Pathogen Panel Multiplex Nucleic Acid-Based Assay System
Xpert Norovirus, GeneXpert Dx Systems (GX-I, GX-11, GX-IV, GX-XVI), GeneXpert Infinity-48 System, GeneXpert Infinity-48s System, GeneXpert Infinity-80 System
| Applicant | Cepheid, Sunnyvale CA, US |
| Decision | Substantially Equivalent, Nov 26, 2014 |
| Received | Sep 5, 2014 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K142501
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.