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 Dec 09, 1994
THYROXINE ENZYME IMMUNOASSAY
K944703
Diagnostic Reagents, Inc.
Chemistry · 77d
Cleared Oct 20, 1994
CEDIA T4 MAB ASSAY
K943019
Microgenics Corp.
Chemistry · 118d
Cleared Jul 28, 1994
CEDIA T4 MAB ASSAY
K942575
Microgenics Corp.
Chemistry · 58d
Cleared Apr 26, 1994
CEDIA T4 MAB ASSAY
K941042
Microgenics Corp.
Chemistry · 50d
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 Jun 24, 1992
THYROXINE (FPIA) KIT
K921904
Tudor Laboratories, Inc.
Chemistry · 64d
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 Apr 16, 1991
IMMULITE(TM) TOTAL T4
K910261
Cirrus Diagnostics, Inc.
Chemistry · 84d
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 Mar 09, 1990
AIA-PACK T4
K896982
Tosoh Corp.
Chemistry · 80d
Cleared Jan 30, 1990
VITRO T4-EIA-XT
K896865
In Vitro Diagnostics, Inc.
Chemistry · 55d
Cleared Dec 12, 1989
D-CHEM TOTAL T4 TEST KIT FOR THYROXINE QUANTITA.
K896329
Photec Diagnostics, Inc.
Chemistry · 40d
Cleared May 22, 1989
T4 CLASP-BEAD EIA KIT
K892853
Biotecx Laboratories, Inc.
Chemistry · 34d
Cleared Apr 14, 1989
EMIT CONVENIENCE PACK: THYROXINE ASSAY
K890831
Syva Co.
Chemistry · 52d