| DeNovo ID | DEN180030 |
| Device Name: | QMS Plazomicin Immunoassay |
| Classification | Plazomicin Test System, Immunoassay |
| Applicant | Microgenics Corporation 46500 Kato Road Fremont, CA 94538 |
| Contact | Minoti Patel |
| Product Code | QDR |
| CFR Regulation Number | 862.3460 [🔎] |
| Decision | Granted (DENG) |
| 510(k) Premarket Notification | Device Classification Under Section 513(f)(2)(de Novo) // Quick Links: Skip To Main Page Content Skip To Search Skip To Topics Menu Skip To Common Lin |
| Review Advisory Board | Toxicology |
| Classification Advisory | Toxicology |
| Type | Direct |
| Date Received | 2018-06-25 |
| Decision Date | 2018-11-19 |
| Reclassification Order: | Reclassification Order |