The following data is part of a premarket notification filed by Roche Diagnostics Corp. with the FDA for Elecsys Testosterone Ii Immunoassay.
| Device ID | K093421 |
| 510k Number | K093421 |
| Device Name: | ELECSYS TESTOSTERONE II IMMUNOASSAY |
| Classification | Radioimmunoassay, Testosterones And Dihydrotestosterone |
| Applicant | ROCHE DIAGNOSTICS CORP. 9115 HAGUE RD. PO BOX 50410 Indianapolis, IN 46250 -0457 |
| Contact | Sarah Baumann |
| Correspondent | Sarah Baumann ROCHE DIAGNOSTICS CORP. 9115 HAGUE RD. PO BOX 50410 Indianapolis, IN 46250 -0457 |
| Product Code | CDZ |
| CFR Regulation Number | 862.1680 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2009-11-03 |
| Decision Date | 2010-04-23 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04015630939312 | K093421 | 000 |
| 04015630939817 | K093421 | 000 |