The following data is part of a premarket notification filed by Roche Diagnostics with the FDA for Elecysys Shbg.
| Device ID | K102814 |
| 510k Number | K102814 |
| Device Name: | ELECYSYS SHBG |
| Classification | Radioimmunoassay, Testosterones And Dihydrotestosterone |
| Applicant | Roche Diagnostics 9115 HAGUE ROAD Indianapolis, IN 46250 -0416 |
| Contact | Kelly French |
| Correspondent | Kelly French Roche Diagnostics 9115 HAGUE ROAD Indianapolis, IN 46250 -0416 |
| Product Code | CDZ |
| CFR Regulation Number | 862.1680 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2010-09-28 |
| Decision Date | 2011-01-20 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04015630939305 | K102814 | 000 |