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 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