510(k) K190275 ยท PMY System, Nucleic Acid Amplification Test, Dna, Carbapenem Non-Susceptible Gram Negative Organism, Colony
GenePOC Carba
| Applicant | Genepoc, Inc., Quebec, CA |
| Decision | Substantially Equivalent, May 10, 2019 |
| Received | Feb 8, 2019 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K190275
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.