The following data is part of a premarket notification filed by Biotecx Laboratories, Inc. with the FDA for Estradiol Direct Ria Kit.
| Device ID | K851540 |
| 510k Number | K851540 |
| Device Name: | ESTRADIOL DIRECT RIA KIT |
| Classification | Radioimmunoassay, Estradiol |
| Applicant | BIOTECX LABORATORIES, INC. P.O. BOX 1421 Friendswood, TX 77546 |
| Contact | Mohan Mehra |
| Correspondent | Mohan Mehra BIOTECX LABORATORIES, INC. P.O. BOX 1421 Friendswood, TX 77546 |
| Product Code | CHP |
| CFR Regulation Number | 862.1260 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1985-04-16 |
| Decision Date | 1985-06-06 |