CDP · Class II · 21 CFR 862.1710

FDA Product Code CDP: Radioimmunoassay, Total Triiodothyronine

Leading manufacturers include Abbott Laboratories, Amersham Corp. and Diagnostic Products Corp..

144
Total
144
Cleared
62d
Avg days
1976
Since
144 devices
49–72 of 144
Cleared May 27, 1988
IMMPULSE T, ASSAY REAGENTS
K881214
Sclavo, Inc.
Toxicology · 67d
Cleared May 27, 1988
AMERLITE TT3 ASSAY, LAN.0003/2003 240/144 KIT
K881373
Amersham Corp.
Chemistry · 56d
Cleared Apr 18, 1988
ABBOTT IMX T3
K880087
Abbott Laboratories
Chemistry · 97d
Cleared Nov 23, 1987
CIBA CORNING MAGIC LITE T3 IMMUNOASSAY
K873945
Ciba Corning Diagnostics Corp.
Chemistry · 56d
Cleared Nov 03, 1987
AMERLITE TT3 ASSAY, LAN.0003/1003/2003
K873858
Amersham Corp.
Chemistry · 42d
Cleared Aug 13, 1987
IMMUBEAD T3 ENZYME IMMUNOASSAY KIT
K872191
Immunotech Corp.
Chemistry · 66d
Cleared Feb 02, 1987
DELFIA(TM) TRIIODOTHYRONINE (T3) KIT
K864452
Lkb Instruments, Inc.
Chemistry · 82d
Cleared Feb 11, 1986
AMERLEX-M T3 RIA KIT FOR SERUM AND PLASMA
K860252
Amersham Corp.
Chemistry · 18d
Cleared May 20, 1985
TDX TOTAL T3
K851676
Abbott Laboratories
Chemistry · 27d
Cleared Sep 05, 1984
AMERLEX-M FREE T-3 RIA
K842949
Amersham Corp.
Chemistry · 61d
Cleared May 07, 1984
CORNING IMMO PHASE FREE T3
K840222
Corning Medical & Scientific
Chemistry · 109d
Cleared Apr 18, 1984
FREE T3 SOLID PHASE RADIOIMMUNOASSAY
K840959
Bd Becton Dickinson Vacutainer Systems Preanalytic
Chemistry · 43d
Cleared Mar 19, 1984
SOPHEIA T3 EIA KIT
K840050
Diagnostic Products Corp.
Chemistry · 73d
Cleared Feb 21, 1984
LEECO T3-QUANT DIAG. KIT
K834348
Leeco Diagnostics, Inc.
Chemistry · 70d
Cleared Feb 04, 1984
T3 RIA
K833853
Syncor Intl. Corp.
Chemistry · 92d
Cleared Jan 30, 1984
ENDAB T3
K834049
Immunotech Corp.
Chemistry · 68d
Cleared Oct 27, 1983
COAT-A-COUNT FREE T3 RIA KIT
K832164
Diagnostic Products Corp.
Chemistry · 114d
Cleared Aug 31, 1983
CORNING'S MAGIC T3(125I) RADIOIMMUNO-
K832353
Corning Medical & Scientific
Chemistry · 44d
Cleared May 25, 1983
AMERLEX FREE T-3 RIA KIT
K830980
Amersham Corp.
Chemistry · 57d
Cleared Apr 08, 1983
LEECO T3-RIA DIAGNOSTIC KIT
K830808
Leeco Diagnostics, Inc.
Chemistry · 25d
Cleared Jun 24, 1982
T3 DIAGNOSTIC KIT RIA
K821725
Diagnostic Reagents, Inc.
Chemistry · 16d
Cleared May 05, 1982
T4 DIAGNOSTIC KIT
K820251
Diagnostic Reagents, Inc.
Chemistry · 96d
Cleared Apr 15, 1982
ENZYM-LINKED T3
K820763
Icl Scientific
Chemistry · 24d
Cleared Oct 02, 1981
QUANTICOAT NEONATAL 125 T4 RADIOIMMUNO
K812611
Kallestad Laboratories, Inc.
Chemistry · 17d