The following data is part of a premarket notification filed by Biotecx Laboratories, Inc. with the FDA for T3 Clasp-bead Eia Kit.
| Device ID | K893620 |
| 510k Number | K893620 |
| Device Name: | T3 CLASP-BEAD EIA KIT |
| Classification | Radioimmunoassay, Total Triiodothyronine |
| 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 | CDP |
| CFR Regulation Number | 862.1710 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1989-05-11 |
| Decision Date | 1989-08-11 |