The following data is part of a premarket notification filed by Diagnostics Biochem Canada, Inc. with the FDA for Testosterone By Enzymeimmunoassay (eia).
| Device ID | K014120 |
| 510k Number | K014120 |
| Device Name: | TESTOSTERONE BY ENZYMEIMMUNOASSAY (EIA) |
| Classification | Radioimmunoassay, Testosterones And Dihydrotestosterone |
| Applicant | DIAGNOSTICS BIOCHEM CANADA, INC. 1020 HARGRIEVE RD. London, Ontario, CA N6e 1p5 |
| Contact | G. R. Dumont |
| Correspondent | G. R. Dumont DIAGNOSTICS BIOCHEM CANADA, INC. 1020 HARGRIEVE RD. London, Ontario, CA N6e 1p5 |
| Product Code | CDZ |
| CFR Regulation Number | 862.1680 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2001-12-17 |
| Decision Date | 2002-02-08 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| B24211TESHUE010 | K014120 | 000 |
| B261CANTE2500 | K014120 | 000 |
| 04049016140085 | K014120 | 000 |