The following data is part of a premarket notification filed by Roche Diagnostics with the FDA for Elecsys Amh.
| Device ID | K203757 |
| 510k Number | K203757 |
| Device Name: | Elecsys AMH |
| Classification | Anti-müllerian Hormone Test System |
| Applicant | Roche Diagnostics 9115 Hague Road Indianapolis, IN 46250 |
| Contact | Edie Eads |
| Correspondent | Edie Eads Roche Diagnostics 9115 Hague Road Indianapolis, IN 46250 |
| Product Code | PQO |
| CFR Regulation Number | 862.1092 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-12-23 |
| Decision Date | 2022-06-10 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 07613336166291 | K203757 | 000 |
| 07613336166284 | K203757 | 000 |