CEC · Class II · 21 CFR 862.1695

FDA Product Code CEC: Radioimmunoassay, Free Thyroxine

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

92
Total
92
Cleared
104d
Avg days
1977
Since
92 devices
25–48 of 92
Cleared Jun 21, 1994
AXSYM FREE THYROXINE ( FREE T4 )
K934544
Abbott Laboratories
Chemistry · 272d
Cleared Apr 26, 1994
CIBA CORNING ACS FT3 IMMUNOASSAY
K940482
Ciba Corning Diagnostics Corp.
Chemistry · 83d
Cleared Jan 24, 1994
COBAS(R) CORE FT4 EIA
K932607
Roche Diagnostic Systems, Inc.
Chemistry · 241d
Cleared Nov 10, 1993
FREE THYROXINE(F T4) METHOD/TECHNICON IMMUNO 1(R)
K930322
Heraeus Kulzer, Inc.
Chemistry · 292d
Cleared Oct 28, 1993
STRATUS FREE THYROXINE (FREE T4) FLUOROMETRIC
K932912
Baxter Diagnostics, Inc.
Chemistry · 134d
Cleared Aug 16, 1993
IMMULITE FREE T4
K931704
Diagnostic Products Corp.
Chemistry · 132d
Cleared May 20, 1993
RADIAS FREE T4 ENZYME IMMUNOASSAY
K931110
Bio-Rad
Chemistry · 78d
Cleared Apr 20, 1993
BECTON DICKINSON SIMULTRAC COMPONENT SYSTEM
K925842
Bd Becton Dickinson Vacutainer Systems Preanalytic
Chemistry · 153d
Cleared Jan 27, 1993
ACCESS(R) FREE T4 ASSAY
K925913
Bio-Rad Laboratories, Inc.
Toxicology · 65d
Cleared Nov 30, 1992
VIDAS FREE THYROXINE(FT4) ASSAY
K925177
Biomerieux Vitek, Inc.
Chemistry · 47d
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 Mar 02, 1992
AMERLITE MAB FT4 ASSAY
K920247
Eastman Kodak Company
Chemistry · 41d
Cleared Oct 07, 1991
AFFINITY FREE T4 TEST SYSTEM
K912698
Bd Becton Dickinson Vacutainer Systems Preanalytic
Chemistry · 111d
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 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 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 Dec 22, 1988
AMERLIITE FT4 ASSAY LAN.0006/2006 240/144 TEST KIT
K883123
Amersham Corp.
Chemistry · 149d