The following data is part of a premarket notification filed by Diagnostics Biochem Canada, Inc. with the FDA for Free Testosterone Enzymeimmunoassay (eia) Kit.
| Device ID | K030730 |
| 510k Number | K030730 |
| Device Name: | FREE TESTOSTERONE ENZYMEIMMUNOASSAY (EIA) KIT |
| 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 | 2003-03-10 |
| Decision Date | 2003-08-18 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00840239046383 | K030730 | 000 |
| B261CANFTE260LC80 | K030730 | 000 |
| B261CANFTE2600 | K030730 | 000 |
| B24211FTEHUE010 | K030730 | 000 |
| 04049016137740 | K030730 | 000 |