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 Syva Co..

121
Total
121
Cleared
50d
Avg days
1976
Since
121 devices
25–48 of 121
Cleared Feb 11, 1986
STRAT TOTAL THYROXINE FLUOROMET ENZYME IMMUNOASSAY
K860421
American Dade
Chemistry · 7d
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 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 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 Jan 02, 1981
IMMU-TRACE T4 RIA PROCEDURE
K803046
American Dade
Chemistry · 32d
Cleared Nov 12, 1980
T4 RADIOIMMUNOASSAY KIT
K802469
American Diagnostic Corp.
Chemistry · 34d
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
Cleared Mar 05, 1980
AMERLEX T-4 RIA KIT
K800300
Amersham Corp.
Chemistry · 23d
Cleared Feb 13, 1980
AMES RIALYZE - CHROMATOGRAPHY TUBES
K800169
Miles Laboratories, Inc.
Chemistry · 19d
Cleared Nov 27, 1979
TETRABEAD - 125 T4 SOLID PHASE DIAG. KIT
K792188
Abbott Laboratories
Immunology · 27d
Cleared Sep 17, 1979
VENTRE/SEP T4 TEST SET
K791368
Ventrex Laboratories, Inc.
Chemistry · 54d
Cleared Jul 30, 1979
QUANTIMUNE T-4 FIA
K790576
Bio-Rad
Chemistry · 124d
Cleared Jun 27, 1979
AUTOPAK TEST DELIVERY SYSTEM
K790907
Micromedic Systems
Chemistry · 47d
Cleared Jun 15, 1979
CENTRIA T4 RIA TEST SET
K790800
Ventrex Laboratories, Inc.
Toxicology · 52d
Cleared May 15, 1979
NEONATAL TY AUTOPAK TEST DELIVERY SYSTEM
K790665
Micromedic Systems
Chemistry · 39d
Cleared Aug 14, 1978
CLINIRIA TOTAL T-4 (RIA) TEST
K781181
Miles Laboratories, Inc.
Chemistry · 31d
Cleared Aug 14, 1978
MICRO THYROXINE REAGENT SYSTEM
K781182
Bd Becton Dickinson Vacutainer Systems Preanalytic
Chemistry · 31d