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
25–48 of 92
Cleared Jul 25, 1997
IMMULITE FREE T4 (2-STEP)
K971792
Diagnostic Products Corp.
Chemistry · 71d
Cleared Apr 28, 1997
FT4 METHOD FOR THE DIMENSION RXL CLINICAL CHEMISTRY SYSTEM
K971141
Dade Chemistry Systems, Inc.
Chemistry · 31d
Cleared Mar 18, 1997
NICHOLS ADVANTAGE CHEMILUMINESCENCE FREE T4- ESTIMATE KIT
K962408
Nichols Institute Diagnostics
Chemistry · 270d
Cleared Mar 18, 1997
VITROS IMMUNODIAGNOSTICS PRODUCTS FREE T4 REAGENT PACK (GEM.1015) FREE T4 CALIBRATORS (GEM.CO15)
K965142
Johnson & Johnson Clinical Diagnostics, Inc.
Chemistry · 85d
Cleared Aug 15, 1996
ACA PLUS FREE THYROXINE(FT4) METHOD
K962602
Dade Intl., Inc.
Chemistry · 44d
Cleared Jun 11, 1996
ELECSYS FT4 ASSAY
K961489
Boehringer Mannheim Corp.
Chemistry · 54d
Cleared Apr 21, 1995
COBAS CORE FREE T3 EIA
K942376
Roche Diagnostic Systems, Inc.
Chemistry · 338d
Cleared Feb 22, 1995
AURA FLEX FT4 200 TEST PACK, FT4 CALIBRATOR PACK
K944697
Organon Teknika Corp.
Chemistry · 152d
Cleared Jul 28, 1994
OPUS FT4 TEST SYSTEM
K940507
Pb Diagnostic Systems, Inc.
Chemistry · 176d
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 Mar 01, 1993
NAT. SCREENING INSTITUTE MICRO-PLATE FREE T4 ASSAY
K925649
Solarcare Technologies Corp,Inc.
Chemistry · 112d
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 Nov 19, 1991
SR1 FREE T4 ENZYME IMMUNOASSAY
K912937
Serono-Baker Diagnostics, Inc.
Chemistry · 137d