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

FDA 510(k) Cleared Enzyme Immunoassay, Non-radiolabeled, Total Thyroxine Devices (Product Code KLI)

86 devices
1–24 of 86
Cleared Oct 18, 2016
VITROS® Automation Solutions
K160495
Ortho-Clinical Diagnostics, Inc.
Chemistry · 239d
Cleared Feb 26, 2009
ADVIA CENTAUR SYSTEM WITH STREAMLAB ANALYTICAL WORKCELL
K082638
Siemens Healthcare Diagnostics, Inc.
Chemistry · 169d
Cleared Dec 09, 2002
ACCESS TOTAL T4 ASSAY
K023369
Beckman Coulter, Inc.
Chemistry · 62d
Cleared Nov 25, 1998
ABBOTT ARCHITECT TOTAL T4
K983440
Abbott Laboratories
Chemistry · 57d
Cleared May 22, 1997
DSL ACTIVE T4 EIA
K971269
Diagnostic Systems Laboratories, Inc.
Chemistry · 48d
Cleared May 16, 1997
SYNCHRON SYSTEMS THYROXINE REAGENT
K971203
Beckman Instruments, Inc.
Chemistry · 45d
Cleared Oct 18, 1996
ISOLAB'S T4 TEST KIT
K951014
Isolab, Inc.
Chemistry · 592d
Cleared Aug 24, 1995
RADIAS NEONATAL T4 ENZYME IMMUNOASSAY
K951321
Bio-Rad
Chemistry · 154d
Cleared Feb 22, 1995
RADIAS TOTAL T4 ENZYME IMMUNOASSAY
K946163
Bio-Rad
Chemistry · 65d
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 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 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

About Product Code KLI - Regulatory Context