The following data is part of a premarket notification filed by Diagnostic Reagents, Inc. with the FDA for Tbg Diagnostic Kit.
| Device ID | K820252 |
| 510k Number | K820252 |
| Device Name: | TBG DIAGNOSTIC KIT |
| Classification | Radioimmunoassay, Thyroxine-binding Globulin |
| Applicant | DIAGNOSTIC REAGENTS, INC. 4221 Richmond Rd., N.W. Walker, MI 49534 |
| Product Code | CEE |
| CFR Regulation Number | 862.1685 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1982-01-29 |
| Decision Date | 1982-05-05 |