510(k) K152614 ยท PMY System, Nucleic Acid Amplification Test, Dna, Carbapenem Non-Susceptible Gram Negative Organism, Colony
Xpert Carba-R
| Applicant | Cepheid, Sunnyvale CA, US |
| Decision | Substantially Equivalent, Mar 7, 2016 |
| Received | Sep 14, 2015 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K152614
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.