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
49–72 of 86
Cleared Aug 13, 1987
IMMUBEAD T4 ENZYME IMMUNOASSAY KIT
K872192
Immunotech Corp.
Chemistry · 66d
Cleared Oct 14, 1986
CIBA CORNING PRISMA T4 LIPIA (LIPOSOME)
K862233
Ciba Corning Diagnostics Corp.
Chemistry · 125d
Cleared Feb 06, 1986
V-TREND EIA T4 ENZYME IMMUNOASSAY TEST KIT
K854971
V-Tech, Inc.
Chemistry · 57d
Cleared Jul 22, 1985
CEDIA TOTAL T4 ASSAY
K852164
Microgenics Corp.
Chemistry · 63d
Cleared May 22, 1984
TECHNICON RA-1000 SYS T4-THYROXINE
K841576
Technicon Instruments Corp.
Chemistry · 35d
Cleared May 22, 1984
TERUMO SENSIBEAD THYROXINE EIA KIT
K841601
Terumo Medical Corp.
Chemistry · 34d
Cleared Mar 15, 1984
RA-1000 SYS-T4(THYROXINE)SERUM ANAL
K834102
Technicon Instruments Corp.
Chemistry · 107d
Cleared Mar 05, 1984
STRATUS TOTAL THYROXINE FLUOROMETRIC
K834210
American Dade
Chemistry · 91d
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 Apr 06, 1982
ENZYMUNE-TEST T4
K820750
Icl Scientific
Chemistry · 18d
Cleared Mar 17, 1981
EMIT-TFG PRISMA THYROXINE ASSAY
K810586
Syva Co.
Chemistry · 13d
Cleared Dec 10, 1980
OREIA-Q-TY, ENZYME IMMUNOASSAY
K802693
Organon, Inc.
Chemistry · 41d
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 Mar 19, 1980
SMAC SYSTEM, T4 METHOD
K800384
Technicon Instruments Corp.
Chemistry · 26d
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
Cleared Feb 01, 1979
EMIT THYROXINE ASSAY
K782085
Syva Co.
Chemistry · 49d
Cleared Dec 04, 1978
COMPUTER, 3500, GILFORD SYSTEM
K781828
Syva Co.
Chemistry · 35d
Cleared Jan 21, 1977
ENIT ABA THYROXINE ASSAY
K770070
Syva Co.
Chemistry · 8d