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 Feb 23, 1989
THYROXINE MICROASSAY
K884260
Diamedix Corp.
Chemistry · 135d
Cleared Feb 17, 1989
EMIT THYROXINE ASSAY
K885141
Syva Co.
Chemistry · 64d
Cleared Feb 17, 1989
ACA THYROXINE (T4 E) METHOD
K885258
The DU Pont Co.
Chemistry · 56d
Cleared Jan 27, 1989
ANALYST THYROXINE (T4) ROTOR
K884700
The DU Pont Co.
Chemistry · 79d
Cleared Dec 09, 1988
MODIFIED CEDIA TOTAL T4 ASSAY
K884634
Microgenics Corp.
Chemistry · 32d
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 Feb 11, 1988
T4 SEROZYME ENZYMEIMMUNOASSAY KIT/MAG. SOLID PHASE
K874866
Serono Diagnostics, Inc.
Chemistry · 76d
Cleared Dec 18, 1987
CIBA CORNING T4 LIPIA (LIPOSOME IMMUNOASSAY)
K874603
Ciba Corning Diagnostics Corp.
Chemistry · 39d
Cleared Nov 05, 1987
AMERLITE TT4 ASSAY (240/480/144 TEST KITS)
K873976
Amersham Corp.
Chemistry · 37d
Cleared Oct 29, 1987
AFFINITY TOTAL THYROXINE IMMUNIT
K873518
Bd Becton Dickinson Vacutainer Systems Preanalytic
Chemistry · 58d
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 Apr 04, 1984
VENTREZYME T4 IMMUNOASSAY T4
K840473
Vxr, Inc.
Chemistry · 61d
Cleared Mar 30, 1984
THYROXINE EMIA
K840241
Collaborative Research, Inc.
Chemistry · 70d
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 Apr 05, 1983
FEKAL CON-TRATE SYSTEM
K830769
Trend Scientific, Inc.
Chemistry · 25d