The following data is part of a premarket notification filed by Biotecx Laboratories, Inc. with the FDA for Tbg 125i Ria Kit, Radioimmuno. Of Serum Thyroxine.
| Device ID | K883765 |
| 510k Number | K883765 |
| Device Name: | TBG 125I RIA KIT, RADIOIMMUNO. OF SERUM THYROXINE |
| Classification | Radioassay, Triiodothyronine Uptake |
| 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 | KHQ |
| CFR Regulation Number | 862.1715 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1988-09-06 |
| Decision Date | 1988-10-31 |