CDX · Class II · 21 CFR 862.1700

FDA Product Code CDX: Radioimmunoassay, Total Thyroxine

Leading manufacturers include Abbott Laboratories, Bd Becton Dickinson Vacutainer Systems Preanalytic and Bio-Rad.

121
Total
121
Cleared
50d
Avg days
1976
Since
121 devices
25–48 of 121
Cleared May 26, 1987
MICROMEDIC NEONATAL T4 KIT
K871008
Micromedic Systems
Chemistry · 74d
Cleared May 14, 1987
CIBA CORNING MAGIC(R) LITE T4 IMMUNOASSAY
K870965
Ciba Corning Diagnostics Corp.
Chemistry · 65d
Cleared Dec 16, 1986
IQ T4 IMMUNOASSAY
K864560
Bd Becton Dickinson Vacutainer Systems Preanalytic
Chemistry · 27d
Cleared Apr 24, 1986
MMS T4 RIA KIT
K861320
Micromedic Systems
Chemistry · 16d
Cleared Feb 11, 1986
STRAT TOTAL THYROXINE FLUOROMET ENZYME IMMUNOASSAY
K860421
American Dade
Chemistry · 7d
Cleared Jan 18, 1984
T4 RIA
K833850
Syncor Intl. Corp.
Chemistry · 75d
Cleared Jun 30, 1983
MAGIC T4 125I RADIOIMMUNOASSAY
K831533
Corning Medical & Scientific
Chemistry · 48d
Cleared May 18, 1983
COAT-A-COUNT NEONATAL T4 KIT RIA KIT
K831107
Diagnostic Products Corp.
Chemistry · 43d
Cleared Dec 09, 1982
MONOCLONAL ANTIBODY T4 RADIO-KIT
K823265
Bd Becton Dickinson Vacutainer Systems Preanalytic
Chemistry · 37d
Cleared Nov 10, 1982
NML-TETRA-TUBE RIA
K823053
Nuclear Medical Laboratories, Inc.
Chemistry · 23d
Cleared Sep 13, 1982
LEECO T4 QUANT DIAGNOSTICS TEST KIT
K822399
Leeco Diagnostics, Inc.
Chemistry · 34d
Cleared Jun 01, 1982
SPAC T4 RIA TEST KIT
K820725
Mallinckrodt Critical Care
Chemistry · 76d
Cleared May 13, 1982
ENDAB T4 ENZYME IMMUNOASSAY KIT
K821141
Immunotech Corp.
Immunology · 22d
Cleared Apr 16, 1982
THYROXINE T4 KIT
K820886
Pcl-Ria, Inc.
Chemistry · 17d
Cleared Jul 10, 1981
QUANTAPHASE T-4 RIA
K811787
Bio-Rad
Chemistry · 17d
Cleared May 27, 1981
COAT-A-COUNT T4 RIA KIT
K811315
Diagnostic Products Corp.
Chemistry · 16d
Cleared Apr 29, 1981
125 I-T4 RIA TEST KIT
K811070
Intl. Immunoassay Laboratories, Inc.
Chemistry · 9d
Cleared Jan 02, 1981
IMMU-TRACE T4 RIA PROCEDURE
K803046
American Dade
Chemistry · 32d
Cleared Nov 24, 1980
SERUM T4 BY ENZYME IMMUNOASSAY
K802573
Worthington Diagnostic Systems
Chemistry · 38d
Cleared Nov 12, 1980
T4 RADIOIMMUNOASSAY KIT
K802469
American Diagnostic Corp.
Chemistry · 34d
Cleared Oct 31, 1980
T4-SQUIBB RIA KIT
K802456
E. R. Squibb & Sons, Inc.
Chemistry · 23d
Cleared Jun 09, 1980
THYROXINE RADIOIMMUNOASSAY KIT
K801105
Calbiochem-Behring Corp.
Chemistry · 31d
Cleared Mar 19, 1980
RIA PHASE T4
K800203
Boehringer Mannheim Corp.
Chemistry · 49d
Cleared Mar 19, 1980
ANALYTE T4-THYROXINE
K800385
Technicon Instruments Corp.
Chemistry · 26d