510(k) K191288 ยท PMY System, Nucleic Acid Amplification Test, Dna, Carbapenem Non-Susceptible Gram Negative Organism, Colony
Acuitas AMR Gene Panel
| Applicant | Opgen, Inc., Rockville MD, US |
| Decision | Substantially Equivalent, Sep 30, 2021 |
| Received | May 13, 2019 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K191288
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.