The following data is part of a premarket notification filed by Biotecx Laboratories, Inc. with the FDA for Opticoat T3 Eia Kit.
| Device ID | K981824 |
| 510k Number | K981824 |
| Device Name: | OPTICOAT T3 EIA KIT |
| Classification | Radioimmunoassay, Total Triiodothyronine |
| Applicant | BIOTECX LABORATORIES, INC. 6023 SOUTH LOOP EAST Houston, TX 77033 |
| Contact | Mohan Mehra |
| Correspondent | Mohan Mehra BIOTECX LABORATORIES, INC. 6023 SOUTH LOOP EAST Houston, TX 77033 |
| Product Code | CDP |
| CFR Regulation Number | 862.1710 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1998-05-22 |
| Decision Date | 1998-12-22 |