510(k) K151565 · OUY Trichomonas Vaginalis Nucleic Acid Amplification Test System
Xpert® TV Assay on the Cepheid GeneXpert Instrument Systems (GeneXpert Dx, GeneXpert Infinity-48, GeneXpert Infinity-48s, and GeneXpertInfinity-80 systems), Xpert Vaginal/Endocervical Specimen Collection Kit, and Xpert Urine Specimen Collection Kit
| Applicant | Cepheid, Sunnyvale CA, US |
| Decision | Substantially Equivalent, Oct 16, 2015 |
| Received | Jun 10, 2015 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K151565
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.