KLI · Class II · 21 CFR 862.1700

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

Leading manufacturers include Syva Co., Abbott Laboratories and Bio-Rad.

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 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 16, 1997
SYNCHRON SYSTEMS THYROXINE REAGENT
K971203
Beckman Instruments, Inc.
Chemistry · 45d
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 Jan 24, 1994
COBAS (R) CORE T4 EIA
K932605
Roche Diagnostic Systems, Inc.
Chemistry · 241d
Cleared Sep 18, 1992
VISTA THYROXINE (T-4) ASSAY -- MODIFICATION
K922433
Syva Co.
Chemistry · 155d
Cleared Dec 09, 1991
CEDIA T4
K915194
Boehringer Mannheim Corp.
Chemistry · 20d
Cleared Aug 23, 1990
IL THYROXINE (T4) ASSAY SYSTEM
K903095
Instrumentation Laboratory CO
Chemistry · 41d
Cleared Apr 14, 1989
EMIT CONVENIENCE PACK: THYROXINE ASSAY
K890831
Syva Co.
Chemistry · 52d
Cleared Feb 17, 1989
EMIT THYROXINE ASSAY
K885141
Syva Co.
Chemistry · 64d
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 Oct 29, 1987
AFFINITY TOTAL THYROXINE IMMUNIT
K873518
Bd Becton Dickinson Vacutainer Systems Preanalytic
Chemistry · 58d
Cleared Apr 06, 1983
TDX THYROXINE
K830683
Abbott Laboratories
Chemistry · 33d
Cleared Feb 07, 1983
PARAMOUNT THYROXINE ASSAY
K830136
Syva Co.
Chemistry · 25d
Cleared Jan 12, 1983
SOPHEIA THYROXINE EIA KIT
K823751
Diagnostic Products Corp.
Chemistry · 29d
Cleared Nov 08, 1982
SYVA ADVANCE THYROXINE ASSAY
K823034
Syva Co.
Toxicology · 18d
Cleared Mar 17, 1981
EMIT-TFG PRISMA THYROXINE ASSAY
K810586
Syva Co.
Chemistry · 13d
Cleared Jul 08, 1980
APPLICATION OF EMIT AED ASSAYS
K801475
Syva Co.
Toxicology · 14d
Cleared Jun 30, 1980
EMIT AAII THYROXINE ASSAY
K801288
Syva Co.
Chemistry · 31d
Cleared Aug 10, 1979
A-GENT QUANTICHROM T4 11A
K790848
Abbott Laboratories
Chemistry · 99d
Cleared May 25, 1979
EMIT CFA THYROXINE ASSAY
K790686
Syva Co.
Chemistry · 44d

About Product Code KLI - Regulatory Context