The following data is part of a premarket notification filed by Diagnostic Reagents, Inc. with the FDA for T3 Diagnostic Kit Ria.
Device ID | K821725 |
510k Number | K821725 |
Device Name: | T3 DIAGNOSTIC KIT RIA |
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 | 1982-06-08 |
Decision Date | 1982-06-24 |