Panels › Microbiology › Product code PMY · Class 2
System, Nucleic Acid Amplification Test, Dna, Carbapenem Non-Susceptible Gram Negative Organism, Colony
Regulation 866.1640
0510(k)s in 12 months (3 all time)
0recalls in 12 months (0 all time)
0recalls that name a 510(k)
Top companies in PMY
| Company | 510(k)s | Recalls |
|---|---|---|
| Cepheid | 1 | 0 |
| Genepoc, Inc. | 1 | 0 |
| Opgen, Inc. | 1 | 0 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Sep 30, 2021 | K191288 | Acuitas AMR Gene Panel Opgen, Inc. | PMY |
| May 10, 2019 | K190275 | GenePOC Carba Genepoc, Inc., CA | PMY |
| Mar 7, 2016 | K152614 | Xpert Carba-R Cepheid | PMY |
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