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
FDA 510(k) Cleared Enzyme Immunoassay, Non-radiolabeled, Total Thyroxine Devices (Product Code KLI)
86 devices
Cleared
Oct 18, 2016
VITROS® Automation Solutions
Ortho-Clinical Diagnostics, Inc.
Chemistry
239d
Cleared
Aug 14, 2013
ACE -GT REAGENT
Alfa Wassermann
Chemistry
78d
Cleared
Apr 22, 2011
GSP NEONATAL THYROXINE (T4)
Wallac Oy, A Subsidiary of Perkinelmer, Inc.
Chemistry
147d
Cleared
Feb 26, 2009
ADVIA CENTAUR SYSTEM WITH STREAMLAB ANALYTICAL WORKCELL
Siemens Healthcare Diagnostics, Inc.
Chemistry
169d
Cleared
Aug 22, 2003
ACCUBIND NEONATAL T4 MICROPLATE EIA, MODEL 2625-300
Monobind
Chemistry
157d
Cleared
Dec 09, 2002
ACCESS TOTAL T4 ASSAY
Beckman Coulter, Inc.
Chemistry
62d
Cleared
Mar 27, 2000
SYVA EMIT 2000 THYROXINE ASSAY, CALIBRATORS
Syva Co., Dade Behring, Inc.
Chemistry
33d
Cleared
Jun 02, 1999
BIOCHECK TOTAL T4 ENZYME IMMUNOASSAY TEST KIT, MODEL BC-1007
Biocheck, Inc.
Chemistry
37d
Cleared
Feb 03, 1999
OPTICOAT T4 EIA KIT
Biotecx Laboratories, Inc.
Chemistry
217d
Cleared
Nov 25, 1998
ABBOTT ARCHITECT TOTAL T4
Abbott Laboratories
Chemistry
57d
Cleared
Jun 10, 1998
ACE T4 REAGENT T4 CALIBRATORS
Schiapparelli Biosystems, Inc.
Chemistry
55d
Cleared
Oct 06, 1997
ACCUWELL T4-EIA
Neometrics, Inc.
Chemistry
56d
Cleared
Jun 16, 1997
TOTAL THROXINE MICROPLATE EIA(225-300)
Monobind
Chemistry
39d
Cleared
May 22, 1997
DSL ACTIVE T4 EIA
Diagnostic Systems Laboratories, Inc.
Chemistry
48d
Cleared
May 16, 1997
SYNCHRON SYSTEMS THYROXINE REAGENT
Beckman Instruments, Inc.
Chemistry
45d
Cleared
Dec 18, 1996
VITROS IMMUNODIAGNOSTICS PRODUCTS TOTAL T4 REAGENT PACK (GEM.1005) TOTAL T4 CALIBRATORS (GEM.C005)
Johnson & Johnson Clinical Diagnostics, Inc.
Chemistry
23d
Cleared
Oct 18, 1996
ISOLAB'S T4 TEST KIT
Isolab, Inc.
Chemistry
592d
Cleared
Jul 08, 1996
UBI MAGIWEL THYROXINE (T4) QUANTITATIVE
United Biotech, Inc.
Chemistry
28d
Cleared
Aug 24, 1995
RADIAS NEONATAL T4 ENZYME IMMUNOASSAY
Bio-Rad
Chemistry
154d
Cleared
Feb 22, 1995
RADIAS TOTAL T4 ENZYME IMMUNOASSAY
Bio-Rad
Chemistry
65d
Cleared
Dec 09, 1994
THYROXINE ENZYME IMMUNOASSAY
Diagnostic Reagents, Inc.
Chemistry
77d
Cleared
Oct 20, 1994
CEDIA T4 MAB ASSAY
Microgenics Corp.
Chemistry
118d
Cleared
Jul 28, 1994
CEDIA T4 MAB ASSAY
Microgenics Corp.
Chemistry
58d
Cleared
Apr 26, 1994
CEDIA T4 MAB ASSAY
Microgenics Corp.
Chemistry
50d