The following data is part of a premarket notification filed by Roche Diagnostics with the FDA for Elecsys Testosterone Ii.
| Device ID | K211685 |
| 510k Number | K211685 |
| Device Name: | Elecsys Testosterone II |
| Classification | Radioimmunoassay, Testosterones And Dihydrotestosterone |
| Applicant | Roche Diagnostics 9115 Hague Road, PO Box 50416 Indianapolis, IN 46250 |
| Contact | Adennis N Cora |
| Correspondent | Justin Davis Roche Diagnostics 9115 Hague Road, PO Box 50416 Indianapolis, IN 46250 |
| Product Code | CDZ |
| CFR Regulation Number | 862.1680 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-06-02 |
| Decision Date | 2022-05-06 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 07613336170571 | K211685 | 000 |
| 07613336170557 | K211685 | 000 |