KLI · Class II · 21 CFR 862.1700

FDA Product Code KLI: Enzyme Immunoassay, Non-radiolabeled, Total Thyroxine

Leading manufacturers include Syva Co., Microgenics Corp. and Abbott Laboratories.

86
Total
86
Cleared
80d
Avg days
1977
Since
86 devices
25–48 of 86
Cleared Mar 03, 1994
CEDIA T4 MAB ASSAY MODIFICATION
K935880
Microgenics Corp.
Chemistry · 87d
Cleared Jan 24, 1994
COBAS (R) CORE T4 EIA
K932605
Roche Diagnostic Systems, Inc.
Chemistry · 241d
Cleared Jun 15, 1993
ACCESS(R) THYROXINE ASSAY
K926475
Bio-Rad Laboratories, Inc.
Chemistry · 168d
Cleared May 13, 1993
VIDAS THYROXINE (T4) ASSAY (T4)
K926393
Biomerieux Vitek, Inc.
Chemistry · 143d
Cleared Sep 18, 1992
VISTA THYROXINE (T-4) ASSAY -- MODIFICATION
K922433
Syva Co.
Chemistry · 155d
Cleared Mar 27, 1992
MEDIX BIOTECH THROXINE ENZYME IMMUNOASSAY TEST KIT
K920712
Medix Biotech, Inc.
Chemistry · 38d
Cleared Dec 09, 1991
CEDIA T4
K915194
Boehringer Mannheim Corp.
Chemistry · 20d
Cleared Sep 25, 1991
TECHNICON IMMUNO 1 TM SYSTEM ADDITIONAL ANALYTES
K912616
Technicon Instruments Corp.
Chemistry · 104d
Cleared Aug 16, 1991
SR1 T4 ENZYME IMMUNOASSAY (MAGNETIC SOLID-PHASE)
K911217
Serono-Baker Diagnostics, Inc.
Chemistry · 150d
Cleared Aug 23, 1990
IL THYROXINE (T4) ASSAY SYSTEM
K903095
Instrumentation Laboratory CO
Chemistry · 41d
Cleared Mar 29, 1990
NDS THYROXINE TEST KIT & NDS THYROXINE CALIBRATOR
K897072
Kallestad Diag, A Div. of Erbamont, Inc.
Chemistry · 97d
Cleared Mar 19, 1990
OPUS T4 TEST SYSTEM
K897193
Pb Diagnostic Systems, Inc.
Toxicology · 80d
Cleared Mar 15, 1990
THYROXIN(T4) ENZYME IMMUNOASSAY TEST KIT
K897144
Medix Biotech, Inc.
Chemistry · 78d
Cleared Apr 14, 1989
EMIT CONVENIENCE PACK: THYROXINE ASSAY
K890831
Syva Co.
Chemistry · 52d
Cleared Feb 23, 1989
THYROXINE MICROASSAY
K884260
Diamedix Corp.
Chemistry · 135d
Cleared Feb 17, 1989
EMIT THYROXINE ASSAY
K885141
Syva Co.
Chemistry · 64d
Cleared Dec 09, 1988
MODIFIED CEDIA TOTAL T4 ASSAY
K884634
Microgenics Corp.
Chemistry · 32d
Cleared May 27, 1988
EMIT CONVENIENCE PACK: THYROXINE ASSAY
K881357
Syva Co.
Chemistry · 57d
Cleared Mar 24, 1988
EMIT THYROXINE ASSAY
K880620
Syva Co.
Chemistry · 37d
Cleared Mar 16, 1988
VISION(R) THYROXINE (T4)
K880662
Abbott Laboratories
Chemistry · 28d
Cleared Feb 11, 1988
T4 SEROZYME ENZYMEIMMUNOASSAY KIT/MAG. SOLID PHASE
K874866
Serono Diagnostics, Inc.
Chemistry · 76d
Cleared Dec 18, 1987
CIBA CORNING T4 LIPIA (LIPOSOME IMMUNOASSAY)
K874603
Ciba Corning Diagnostics Corp.
Chemistry · 39d
Cleared Nov 05, 1987
AMERLITE TT4 ASSAY (240/480/144 TEST KITS)
K873976
Amersham Corp.
Chemistry · 37d
Cleared Oct 29, 1987
AFFINITY TOTAL THYROXINE IMMUNIT
K873518
Bd Becton Dickinson Vacutainer Systems Preanalytic
Chemistry · 58d