The following data is part of a De Novo classification by Roche Diagnostics with the FDA for Elecsys Amh, Amh Calset, Precicontrol Amh, Amh Calcheck 5.
| DeNovo ID | DEN150057 |
| Device Name: | Elecsys AMH, AMH CalSet, PreciControl AMH, AMH CalCheck 5 |
| Classification | Anti-müllerian Hormone Test System |
| Applicant | ROCHE DIAGNOSTICS 9115 Hague Road Indianapolis, IN 46250 |
| Contact | Edie Eads |
| Product Code | PQO |
| CFR Regulation Number | 862.1092 [🔎] |
| 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 | Clinical Chemistry |
| Classification Advisory | Clinical Chemistry |
| Type | Direct |
| Date Received | 2015-12-09 |
| Decision Date | 2016-12-19 |
| FDA Review | Decision Summary |
| Reclassification Order: | Reclassification Order |