The following data is part of a premarket notification filed by Biotecx Laboratories, Inc. with the FDA for Progesterone Clasp Radioimmunoassay Kit.
| Device ID | K871211 |
| 510k Number | K871211 |
| Device Name: | PROGESTERONE CLASP RADIOIMMUNOASSAY KIT |
| Classification | Radioimmunoassay, Progesterone |
| Applicant | BIOTECX LABORATORIES, INC. P.O. BOX 1421 Friendswood, TX 77546 |
| Contact | Mehra, Ph.d. |
| Correspondent | Mehra, Ph.d. BIOTECX LABORATORIES, INC. P.O. BOX 1421 Friendswood, TX 77546 |
| Product Code | JLS |
| CFR Regulation Number | 862.1620 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1987-03-26 |
| Decision Date | 1987-04-13 |