510(k) K160901 ยท POC System, Nucleic Acid Amplification Test, Dna, Antimicrobial Resistance Marker, Direct Specimen
Xpert Carba-R
| Applicant | Cepheid, Sunnyvale CA, US |
| Decision | Substantially Equivalent, Jun 29, 2016 |
| Received | Apr 1, 2016 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K160901
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.