CEC · Class II · 21 CFR 862.1695

FDA Product Code CEC: Radioimmunoassay, Free Thyroxine

Leading manufacturers include Bd Becton Dickinson Vacutainer Systems Preanalytic, Abbott Laboratories and Amersham Corp..

92
Total
92
Cleared
104d
Avg days
1977
Since
92 devices
49–72 of 92
Cleared Nov 16, 1992
VISTA FREE THYROXINE ASSAY
K923572
Syva Co.
Chemistry · 122d
Cleared Oct 26, 1992
KODAK AMERLITE MAB FT3 ASSAY
K922713
Eastman Kodak Company
Chemistry · 143d
Cleared Jul 10, 1992
ELEGANCE FT4 ELISA
K922284
Bioclone Australia Pty , Ltd.
Chemistry · 56d
Cleared Mar 02, 1992
AMERLITE MAB FT4 ASSAY
K920247
Eastman Kodak Company
Chemistry · 41d
Cleared Dec 17, 1991
LUMATAG FREE T4 CHEMILUMINESCENCE ASSAY
K914835
London Diagnostics, Inc.
Chemistry · 53d
Cleared Nov 19, 1991
SR1 FREE T4 ENZYME IMMUNOASSAY
K912937
Serono-Baker Diagnostics, Inc.
Chemistry · 137d
Cleared Oct 07, 1991
AFFINITY FREE T4 TEST SYSTEM
K912698
Bd Becton Dickinson Vacutainer Systems Preanalytic
Chemistry · 111d
Cleared Sep 10, 1991
AIA-PACK FT4
K913493
Tosoh Corp.
Chemistry · 35d
Cleared Jun 24, 1991
MICROZYME(TM) FREE T4 ENZYME IMMUNOASSAY TEST
K911634
Immunotech Corp.
Chemistry · 74d
Cleared May 01, 1991
CIBA CORNING ACS FT4 IMMUNOASSAY
K910684
Ciba Corning Diagnostics Corp.
Chemistry · 71d
Cleared Nov 30, 1990
FLAGEN TM FREE T4
K904539
Cyberfluor, Inc.
Chemistry · 57d
Cleared Sep 10, 1990
TDX FREE T4 CALCULATION
K903383
Abbott Laboratories
Chemistry · 45d
Cleared Sep 10, 1990
IMX FREE T4 CALCULATION
K903384
Abbott Laboratories
Chemistry · 45d
Cleared Sep 07, 1990
ABBOTT IMX FREE T4
K902834
Abbott Laboratories
Chemistry · 71d
Cleared May 15, 1990
ENZYMUN TEST(R) FT4 (FREE THYROXINE)
K900883
Boehringer Mannheim Corp.
Chemistry · 78d
Cleared Mar 29, 1990
FREE T4 IMMUNOASSAY KIT
K900060
Advanced Magnetics, Inc.
Chemistry · 85d
Cleared Nov 17, 1989
FREE THYROXINE (FT4) RADIOIMMUNOASSAY KIT
K896222
Nichols Institute Diagnostics
Chemistry · 18d
Cleared Sep 18, 1989
DELFIA FREE THYROXINE (FT4) KIT
K894605
Pharmacia, Inc.
Chemistry · 60d
Cleared Aug 03, 1989
AMERLEX-MAB FT4 KIT
K894091
Amersham Corp.
Chemistry · 55d
Cleared Feb 27, 1989
MODIFIED FREE T4 RADIOIMMUNOASSAY KIT
K884753
Advanced Magnetics, Inc.
Chemistry · 105d
Cleared Dec 22, 1988
AMERLIITE FT4 ASSAY LAN.0006/2006 240/144 TEST KIT
K883123
Amersham Corp.
Chemistry · 149d
Cleared Oct 25, 1988
QLIA T UPTAKE ASSAY
K883971
Bd Becton Dickinson Vacutainer Systems Preanalytic
Chemistry · 35d
Cleared Mar 24, 1988
CHEMELIA FREE THYROXINE(FT4)/ENZYME IMMUNO. (EIA)
K874875
Boots-Celltech Diagnostics, Inc.
Chemistry · 118d
Cleared Sep 14, 1987
DIAGNOSTIC KIT FREE T3 AND FREE T4
K870268
Sclavo, Inc.
Chemistry · 234d