The following data is part of a premarket notification filed by Biotecx Laboratories, Inc. with the FDA for Aldosterone Direct Ria Kit.
| Device ID | K854876 |
| 510k Number | K854876 |
| Device Name: | ALDOSTERONE DIRECT RIA KIT |
| Classification | Radioassay, Angiotensin Converting Enzyme |
| 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 | KQN |
| CFR Regulation Number | 862.1090 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1985-12-06 |
| Decision Date | 1986-03-17 |