510(k) K161619 ยท OUY Trichomonas Vaginalis Nucleic Acid Amplification Test System
Xpert TV, Xpert Urine Specimen Collection Kit, GeneXpert Dx Systems (GX-I, GX-II, GX-IV, GX-XVI), GeneXpert Infinity-48, Genxpert Infinity-48s and GeneXpert Infinity-80 Systems
| Applicant | Cepheid, Sunnyvale CA, US |
| Decision | Substantially Equivalent, Aug 29, 2016 |
| Received | Jun 13, 2016 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K161619
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.