The following data is part of a premarket notification filed by Biocheck, Inc. with the FDA for Total T3 Enzyme Immunoassay Test Kit, Model Bc-1005.
| Device ID | K991311 |
| 510k Number | K991311 |
| Device Name: | TOTAL T3 ENZYME IMMUNOASSAY TEST KIT, MODEL BC-1005 |
| Classification | Radioimmunoassay, Total Triiodothyronine |
| Applicant | BIOCHECK, INC. 9418 LASAINE AVE. Northridge, CA 91325 |
| Contact | Robin J Hellen |
| Correspondent | Robin J Hellen BIOCHECK, INC. 9418 LASAINE AVE. Northridge, CA 91325 |
| Product Code | CDP |
| CFR Regulation Number | 862.1710 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1999-04-16 |
| Decision Date | 1999-06-02 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00811727013132 | K991311 | 000 |
| 00850392007053 | K991311 | 000 |
| 00840239017802 | K991311 | 000 |
| 04048474017809 | K991311 | 000 |