The following data is part of a premarket notification filed by Clinical Diagnostics, Inc. with the FDA for Centria T4 Ria.
Device ID | K761272 |
510k Number | K761272 |
Device Name: | CENTRIA T4 RIA |
Classification | Radioimmunoassay, Total Thyroxine |
Applicant | CLINICAL DIAGNOSTICS, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Product Code | CDX |
CFR Regulation Number | 862.1700 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1976-12-20 |
Decision Date | 1977-03-16 |