The following data is part of a premarket notification filed by Biocheck, Inc. with the FDA for Biocheck Testosterone Eia, Model Bc-1115.
| Device ID | K002294 |
| 510k Number | K002294 |
| Device Name: | BIOCHECK TESTOSTERONE EIA, MODEL BC-1115 |
| Classification | Radioimmunoassay, Testosterones And Dihydrotestosterone |
| Applicant | BIOCHECK, INC. 9418 LASAINE AVE. Northridge, CA 91325 |
| Contact | Robin J Hellen |
| Correspondent | Robin J Hellen BIOCHECK, INC. 9418 LASAINE AVE. Northridge, CA 91325 |
| Product Code | CDZ |
| CFR Regulation Number | 862.1680 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2000-07-27 |
| Decision Date | 2000-10-02 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00811727013309 | K002294 | 000 |
| 00850392007152 | K002294 | 000 |