The following data is part of a premarket notification filed by Diagnostic Reagents, Inc. with the FDA for T4 Diagnostic Kit.
Device ID | K820251 |
510k Number | K820251 |
Device Name: | T4 DIAGNOSTIC KIT |
Classification | Radioimmunoassay, Total Triiodothyronine |
Applicant | DIAGNOSTIC REAGENTS, INC. 4221 Richmond Rd., N.W. Walker, MI 49534 |
Product Code | CDP |
CFR Regulation Number | 862.1710 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1982-01-29 |
Decision Date | 1982-05-05 |