The following data is part of a premarket notification filed by Biotecx Laboratories, Inc. with the FDA for Dhea-s Direct Ria Kit.
| Device ID | K842555 |
| 510k Number | K842555 |
| Device Name: | DHEA-S DIRECT RIA KIT |
| Classification | Radioimmunoassay, Dehydroepiandrosterone (free And Sulfate) |
| Applicant | BIOTECX LABORATORIES, INC. 4221 Richmond Rd., N.W. Walker, MI 49534 |
| Product Code | JKC |
| CFR Regulation Number | 862.1245 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1984-07-02 |
| Decision Date | 1984-08-07 |