FDA 510(k) Applications for Medical Device Product Code "CEC"
(Radioimmunoassay, Free Thyroxine)

FDA 510(k) Number Applicant Device Name Decision Date
K123379 ABBOTT LABORATORIES ABBOTT ARCHITECT FREE T4 11/27/2012
K983417 ABBOTT LABORATORIES ABBOTT ARCHITECT FREE T4 11/20/1998
K902834 ABBOTT LABORATORIES ABBOTT IMX FREE T4 09/07/1990
K934544 ABBOTT LABORATORIES AXSYM FREE THYROXINE ( FREE T4 ) 06/21/1994
K903384 ABBOTT LABORATORIES IMX FREE T4 CALCULATION 09/10/1990
K903383 ABBOTT LABORATORIES TDX FREE T4 CALCULATION 09/10/1990
K771236 ABBOTT LABORATORIES TRIOBEAD-125 DIAGNOSTIC KIT 08/03/1977
K900060 ADVANCED MAGNETICS, INC. FREE T4 IMMUNOASSAY KIT 03/29/1990
K884753 ADVANCED MAGNETICS, INC. MODIFIED FREE T4 RADIOIMMUNOASSAY KIT 02/27/1989
K870158 AMERICAN DADE STRATUS FREE THYROXINE (FT4) FLUOR. ENZYME IMMUNO. 03/19/1987
K842482 AMERSHAM CORP. AMERLEX-M FREE T-4 RADIOIMMUNOASSAY KIT 08/10/1984
K860251 AMERSHAM CORP. AMERLEX-M T4 RIA KIT FOR SERUM AND PLASMA 02/11/1986
K894091 AMERSHAM CORP. AMERLEX-MAB FT4 KIT 08/03/1989
K883123 AMERSHAM CORP. AMERLIITE FT4 ASSAY LAN.0006/2006 240/144 TEST KIT 12/22/1988
K810231 AMERSHAM CORP. CODE IM 2050 AMERLEX FREE T4 RIA KIT 02/10/1981
K932912 BAXTER DIAGNOSTICS, INC. STRATUS FREE THYROXINE (FREE T4) FLUOROMETRIC 10/28/1993
K912698 BD BECTON DICKINSON VACUTAINER SYSTEMS PREANALYTIC AFFINITY FREE T4 TEST SYSTEM 10/07/1991
K925842 BD BECTON DICKINSON VACUTAINER SYSTEMS PREANALYTIC BECTON DICKINSON SIMULTRAC COMPONENT SYSTEM 04/20/1993
K864658 BD BECTON DICKINSON VACUTAINER SYSTEMS PREANALYTIC IQ FREE T4 IMMUNOASSAY 03/12/1987
K865104 BD BECTON DICKINSON VACUTAINER SYSTEMS PREANALYTIC IQ FTI IMMUNOASSAY 03/16/1987
K883971 BD BECTON DICKINSON VACUTAINER SYSTEMS PREANALYTIC QLIA T UPTAKE ASSAY 10/25/1988
K853628 BD BECTON DICKINSON VACUTAINER SYSTEMS PREANALYTIC SIMULTRAC FREE T4(57CO)/TSH[125I] RADIOIMMUNOASSAY 09/18/1985
K864838 BD BECTON DICKINSON VACUTAINER SYSTEMS PREANALYTIC SIMULTRAC FREE T4[57CO]/TSH MAB[125I] 02/18/1987
K823264 BD BECTON DICKINSON VACUTAINER SYSTEMS PREANALYTIC THYROXINE ANALYSIS PRODUCTS/RADIO-FREE 01/12/1983
K982250 BECKMAN INSTRUMENTS, INC. ACCESS FREE T4 REAGENTS ON THE ACCESS IMMUNOASSAY ANALYZER 07/14/1998
K931110 BIO-RAD RADIAS FREE T4 ENZYME IMMUNOASSAY 05/20/1993
K925913 BIO-RAD LABORATORIES, INC. ACCESS(R) FREE T4 ASSAY 01/27/1993
K980819 BIOCIRCUITS CORP. BIOCIRCUITS IOS FREE THYROXINE (FT4) TEST CARTRIDGES BIOCIRCUITS IOS CONTROLS 04/03/1998
K823005 BIOCLINICAL GROUP BIO MAG FREE T4 RADIOIMMUNOASSAY KIT 12/15/1982
K821241 BIOCLINICAL GROUP FREE T4 RADIOIMMUNOASSAY KIT 06/01/1982
K922284 BIOCLONE AUSTRALIA PTY LTD. ELEGANCE FT4 ELISA 07/10/1992
K982954 BIOMERICA, INC. FREE T4 MICROWELL EIA, MODEL #7019 09/24/1998
K925177 BIOMERIEUX VITEK, INC. VIDAS FREE THYROXINE(FT4) ASSAY 11/30/1992
K981243 BIOSTRIDE DIAGNOSTICS, INC. BIOSTRIDE FREE T4 EIA TEST KIT 06/29/1998
K961489 BOEHRINGER MANNHEIM CORP. ELECSYS FT4 ASSAY 06/11/1996
K900883 BOEHRINGER MANNHEIM CORP. ENZYMUN TEST(R) FT4 (FREE THYROXINE) 05/15/1990
K874875 BOOTS-CELLTECH DIAGNOSTICS, INC. CHEMELIA FREE THYROXINE(FT4)/ENZYME IMMUNO. (EIA) 03/24/1988
K940482 CIBA CORNING DIAGNOSTICS CORP. CIBA CORNING ACS FT3 IMMUNOASSAY 04/26/1994
K910684 CIBA CORNING DIAGNOSTICS CORP. CIBA CORNING ACS FT4 IMMUNOASSAY 05/01/1991
K832381 CORNING MEDICAL & SCIENTIFIC CORNING MAGIC SINGLE STEP FREE T4 09/01/1983
K772194 CORNING MEDICAL & SCIENTIFIC IMMO PHASE FT4 ASSAY 01/06/1978
K823144 CORNING MEDICAL & SCIENTIFIC SINGLE STEP FREE-T4 125I RADIOIMMUNO- 11/29/1982
K904539 CYBERFLUOR, INC. FLAGEN TM FREE T4 11/30/1990
K073604 DADE BEHRING, INC. DIMENSION EXL WITH LM CLINICAL CHEMISTRY SYSTEM, DIMENSION FT4L FLEX REAGENT CARTRIDGE, AND LOCI THYROID CALIBRATOR, MOD 03/13/2008
K053531 DADE BEHRING, INC. DIMENSION VISTA FREE THYROXINE FLEX REAGENT CARTRIDGE AND LOCI 1 CALIBRATOR 03/03/2006
K971141 DADE CHEMISTRY SYSTEMS, INC. FT4 METHOD FOR THE DIMENSION RXL CLINICAL CHEMISTRY SYSTEM 04/28/1997
K962602 DADE INTL., INC. ACA PLUS FREE THYROXINE(FT4) METHOD 08/15/1996
K781012 DAMON CORP. RIA TEST KIT SYS. DAMON KIQUISOL FREE 07/27/1978
K822882 DIAGNOSTIC PRODUCTS CORP. COAT-A-COUNT FREE THYROXINE KIT/COMPONEN 11/05/1982
K931704 DIAGNOSTIC PRODUCTS CORP. IMMULITE FREE T4 08/16/1993
K971792 DIAGNOSTIC PRODUCTS CORP. IMMULITE FREE T4 (2-STEP) 07/25/1997
K121951 DIASORIN, INC. LIAISON FT4 LIAISON CONTROL THYROID 1 LIAISON CONTROL THYROID 2 LIAISON CONTROL THYROID 3 04/04/2013
K920247 EASTMAN KODAK COMPANY AMERLITE MAB FT4 ASSAY 03/02/1992
K922713 EASTMAN KODAK COMPANY KODAK AMERLITE MAB FT3 ASSAY 10/26/1992
K930322 HERAEUS KULZER, INC. FREE THYROXINE(F T4) METHOD/TECHNICON IMMUNO 1(R) 11/10/1993
K911634 IMMUNOTECH CORP. MICROZYME(TM) FREE T4 ENZYME IMMUNOASSAY TEST 06/24/1991
K934012 IMMUNOTECH S.A. FT4 RADIOIMMUNOASSAY 11/16/1993
K965142 JOHNSON & JOHNSON CLINICAL DIAGNOSTICS, INC. VITROS IMMUNODIAGNOSTICS PRODUCTS FREE T4 REAGENT PACK (GEM.1015) FREE T4 CALIBRATORS (GEM.CO15) 03/18/1997
K955097 KODAK CLINICAL DIAGNOSTICS, LTD. AMERLITE MAB FT4 ASSAY 12/20/1995
K914835 LONDON DIAGNOSTICS, INC. LUMATAG FREE T4 CHEMILUMINESCENCE ASSAY 12/17/1991
K840901 MEDICAL & SCIENTIFIC DESIGNS, INC. PHASE II FREE T4 KIT 04/25/1984
K020548 MONOBIND FREE T4 (THYTOXINE) MICROPLATE EIA TEST MODELS # 1225-300 04/05/2002
K896222 NICHOLS INSTITUTE DIAGNOSTICS FREE THYROXINE (FT4) RADIOIMMUNOASSAY KIT 11/17/1989
K962408 NICHOLS INSTITUTE DIAGNOSTICS NICHOLS ADVANTAGE CHEMILUMINESCENCE FREE T4- ESTIMATE KIT 03/18/1997
K781560 NUCLEAR DIAGNOSTICS, INC. RIA DIAG. TEST KIT FOR INDEXING THYROX. 10/17/1978
K070708 OLYMPUS LIFE & MATERIAL SCIENCE EUROPA GMBH (IRISH OLYMPUS FT4-FREE THYROXINE, OLYMPUS T4- TOTAL THYROXINE, MODEL# OSR210102, OSR210104 08/21/2007
K944697 ORGANON TEKNIKA CORP. AURA FLEX FT4 200 TEST PACK, FT4 CALIBRATOR PACK 02/22/1995
K940507 PB DIAGNOSTIC SYSTEMS, INC. OPUS FT4 TEST SYSTEM 07/28/1994
K894605 PHARMACIA, INC. DELFIA FREE THYROXINE (FT4) KIT 09/18/1989
K030329 QUALIGEN, INC. FASTPACK FREE T4 IMMUNOASSAY 07/03/2003
K942376 ROCHE DIAGNOSTIC SYSTEMS, INC. COBAS CORE FREE T3 EIA 04/21/1995
K932607 ROCHE DIAGNOSTIC SYSTEMS, INC. COBAS(R) CORE FT4 EIA 01/24/1994
K131244 ROCHE DIAGNOSTICS ELECSYS FT4 II ASSAY, ELECSYS FT4 II CALSET 01/27/2014
K870268 SCLAVO, INC. DIAGNOSTIC KIT FREE T3 AND FREE T4 09/14/1987
K974551 SEALITE SCIENCES, INC. SEALITE SCIENCES, INC. AQUALITE FREE T, ASSAY 12/22/1997
K912937 SERONO-BAKER DIAGNOSTICS, INC. SR1 FREE T4 ENZYME IMMUNOASSAY 11/19/1991
K080167 SIEMENS HEALTHCARE DIAGNOSTICS ACS 180 AND ADVIA CENTAUR FT4 IMMUNOASSAYS 08/08/2008
K132249 SIEMENS HEALTHCARE DIAGNOSTICS INC. ADVIA CENTAUR FT4, ADVIA CENTAUR T4 09/13/2013
K140842 Siemens Healthcare Diagnostics Inc. DIMENSION LOCI FREE THYROXINE FLEX REAGENT CARTRIDGE, FT4L, DIMENSION LOCI THYROID STIMULATING HORMONE FLEX REAGENT CART 11/26/2014
K140859 Siemens Healthcare Diagnostics Inc. DIMENSION VISTA FREE THYROXINE FLEX REAGENT CARTRIDGE, FT4, DIMENSION VISTA THYROID STIMULATING HORMONE FLEX REAGENT 11/26/2014
K083373 SIEMENS HEALTHCARE DIAGNOSTICS INC. IMMULITE 2000 FREE T4 02/02/2009
K925649 SOLARCARE TECHNOLOGIES CORP,INC. NAT. SCREENING INSTITUTE MICRO-PLATE FREE T4 ASSAY 03/01/1993
K923572 SYVA CO. VISTA FREE THYROXINE ASSAY 11/16/1992
K913493 TOSOH CORP. AIA-PACK FT4 09/10/1991
K813465 VENTREX LABORATORIES, INC. FREE T4 RIA TEST SET 12/31/1981


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