The following data is part of a premarket notification filed by Roche Diagnostics with the FDA for Elecsys Hcg Stat.
| Device ID | K203227 |
| 510k Number | K203227 |
| Device Name: | Elecsys HCG STAT |
| Classification | System, Test, Human Chorionic Gonadotropin |
| Applicant | ROCHE DIAGNOSTICS 9115 Hague Road PO Box 50416 Indianapolis, IN 46250 |
| Contact | Adennis N. Cora |
| Correspondent | Adennis N. Cora ROCHE DIAGNOSTICS 9115 Hague Road PO Box 50416 Indianapolis, IN 46250 |
| Product Code | DHA |
| CFR Regulation Number | 862.1155 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-11-02 |
| Decision Date | 2021-08-18 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 07613336169223 | K203227 | 000 |
| 07613336169216 | K203227 | 000 |