FDA 510(k) Applications for Medical Device Product Code "CDP"
(Radioimmunoassay, Total Triiodothyronine)

FDA 510(k) Number Applicant Device Name Decision Date
K983439 ABBOTT LABORATORIES ABBOTT ARCHITECT FREE T3 11/20/1998
K983434 ABBOTT LABORATORIES ABBOTT ARCHITECT TOTAL T3 11/20/1998
K880087 ABBOTT LABORATORIES ABBOTT IMX T3 04/18/1988
K894238 ABBOTT LABORATORIES ABBOTT TDX TOTAL T3 PLUS 10/31/1989
K963827 ABBOTT LABORATORIES AXSYM FREE TRIIODOTHYRONINE (FREE T3) 10/30/1996
K934517 ABBOTT LABORATORIES AXSYM TOTAL T3 06/21/1994
K903432 ABBOTT LABORATORIES IMX FREE T3 CALCULATION 09/07/1990
K905261 ABBOTT LABORATORIES IMX FREE TRIIODOTHYRONINE 01/23/1991
K963833 ABBOTT LABORATORIES IMX FREE TRIIODOTHYRONINE (FREE T3) 10/30/1996
K770201 ABBOTT LABORATORIES T3 RIA (PEG) DIAGNOSTIC KIT 04/05/1977
K803261 ABBOTT LABORATORIES T3 RIABEAD DIAGNOSTIC KIT 01/15/1981
K903433 ABBOTT LABORATORIES TDX FREE T3 CALCULATION 10/12/1990
K851676 ABBOTT LABORATORIES TDX TOTAL T3 05/20/1985
K894200 ADVANCED MAGNETICS, INC. FREE T3 RADIOIMMUNOASSAY KIT 09/25/1989
K974027 ALFA BIOTECH (UK) LTD. AURAFLEX FT3 150 TEST PACK, AURAFLEX FT3 CALIBRATOR PACK 02/02/1998
K780492 ALPHA GAMMA LABORATORY GAMMA STIK 125I T3 UPTAKE KIT 04/28/1978
K842590 AMERICAN BIO-SCIENCE LABORATORIES AMER. BIO-SCIENCE LAB T3 REAGENTS 08/10/1984
K802470 AMERICAN DIAGNOSTIC CORP. T3 RADIOIMMUNOASSAY KIT 11/12/1980
K830980 AMERSHAM CORP. AMERLEX FREE T-3 RIA KIT 05/25/1983
K800374 AMERSHAM CORP. AMERLEX T-3 RIA KIT 03/12/1980
K842949 AMERSHAM CORP. AMERLEX-M FREE T-3 RIA 09/05/1984
K860252 AMERSHAM CORP. AMERLEX-M T3 RIA KIT FOR SERUM AND PLASMA 02/11/1986
K885195 AMERSHAM CORP. AMERLITE FT3 ASSAY, LAN.0007/2007 240/144 TEST KIT 02/08/1989
K873858 AMERSHAM CORP. AMERLITE TT3 ASSAY, LAN.0003/1003/2003 11/03/1987
K881373 AMERSHAM CORP. AMERLITE TT3 ASSAY, LAN.0003/2003 240/144 KIT 05/27/1988
K772122 ANTIBODIES INC. T3 RIA KIT 11/17/1977
K883479 BAXTER HEALTHCARE CORP. STRATUS TOTAL TRIIODOTHYRONINE T3 FLUORO. ENZYME 10/25/1988
K894993 BAXTER HEALTHCARE CORP. STRATUS(R) TOTAL TRIIODOTHYRONINE (T3) F.E.I. 10/13/1989
K962355 BAYER CORP. FREE TRIIODOTHYRONINE(FT3) ASSAY FOR THE TECHNICON IMMUNO 1 SYSTEM (IN-VITRO DIAGNOSTIC SYSTEM) 07/12/1996
K840959 BD BECTON DICKINSON VACUTAINER SYSTEMS PREANALYTIC FREE T3 SOLID PHASE RADIOIMMUNOASSAY 04/18/1984
K800436 BD BECTON DICKINSON VACUTAINER SYSTEMS PREANALYTIC T3 SOLID PHASE RADIOIMMUNOASSAY KIT 03/19/1980
K780787 BD BECTON DICKINSON VACUTAINER SYSTEMS PREANALYTIC TRIIODOTHYRONINE RADIOIMMUNOASSAY KIT 06/06/1978
K973966 BECKMAN INSTRUMENTS, INC. ACCESS TOTAL T3 REAGENTS ON THE ACCESS IMMUNOASSAY ANALYZER 10/31/1997
K953160 BEHRING DIAGNOSTICS, INC. OPUS T3 08/24/1995
K831434 BERWICK MEDICAL PRODUCTS, INC. ISO-SEP SYSTEM 06/30/1983
K790960 BIO-RAD QUANTIMUNE T-3 FIA 08/10/1979
K770648 BIO-RAD QUANTIMUNE T-3 RIA 06/14/1977
K960913 BIO-RAD LABORATORIES, INC. ACCESS FREE T3 ASSAY 03/29/1996
K955435 BIO-RAD LABORATORIES, INC. ACCESS TOTAL T3 ASSAY (MODIFICATION) 01/24/1996
K940833 BIO-RAD LABORATORIES, INC. ACCESS(R) TOTAL T3 09/07/1994
K991311 BIOCHECK, INC. TOTAL T3 ENZYME IMMUNOASSAY TEST KIT, MODEL BC-1005 06/02/1999
K960412 BIOMERICA, INC. T-3 MICROWELL EIA MODEL 7013 03/19/1996
K934764 BIOMERIEUX VITEK, INC. "VIDAS T3" ASSAY 03/22/1994
K981824 BIOTECX LABORATORIES, INC. OPTICOAT T3 EIA KIT 12/22/1998
K893620 BIOTECX LABORATORIES, INC. T3 CLASP-BEAD EIA KIT 08/11/1989
K963127 BOEHRINGER MANNHEIM CORP. ELECSYS FT3 12/16/1996
K962508 BOEHRINGER MANNHEIM CORP. ELECSYS T3 08/15/1996
K896900 BOEHRINGER MANNHEIM CORP. ENZYMUN TEST R T3 02/08/1990
K962760 BOEHRINGER MANNHEIM CORP. ENZYMUN-TEST FT3 11/29/1996
K791232 BURROUGHS WELLCOME CO. DAC-CEL T3 09/04/1979
K801123 CALBIOCHEM-BEHRING CORP. TRIIODOTHYRONINE RADIOIMMUN. SYSTEM 06/09/1980
K873737 CAMBRIDGE MEDICAL TECHNOLOGY NO SPIN(TM) T3 COATED TUBE RADIOIMMUNOASSAY 11/24/1987
K870968 CANADIAN BIOCLINICAL, LTD. TOTAL T3-RIA KIT COATED TUBE RADIOIMMUNOASSAY KIT 06/22/1987
K915792 CASCO STANDARDS DOCUMENT CK ISOENZYMES CONTROL 02/06/1992
K991692 CHIRON DIAGNOSTICS CORP. CHIRON DIAGNOSTICS ACS: 180 FT3 06/18/1999
K932747 CIBA CORNING DIAGNOSTICS CORP. CIBA CORNING ACS FREE T3 IMMUNOASSAY 12/03/1993
K873945 CIBA CORNING DIAGNOSTICS CORP. CIBA CORNING MAGIC LITE T3 IMMUNOASSAY 11/23/1987
K905214 CIRRUS DIAGNOSTICS, INC. IMMULITE (TM) TOTAL T3 02/01/1991
K772108 CLINICAL ASSAYS, INC. IN VITRO T3 RIA TEST 11/17/1977
K780499 CLINICAL BIORESEARCH CBR-T3RIA KIT 05/04/1978
K780018 CLINICAL IMMUNO-DIAGNOSTICS THYRO-INDICATOR T-3 125I 02/07/1978
K840222 CORNING MEDICAL & SCIENTIFIC CORNING IMMO PHASE FREE T3 05/07/1984
K832353 CORNING MEDICAL & SCIENTIFIC CORNING'S MAGIC T3(125I) RADIOIMMUNO- 08/31/1983
K905656 CYBERFLUOR, INC. FLAGEN TRIIODOTHYRONINE (T3) ASSAY 01/23/1991
K770918 DAMON CORP. LIQUI SOL T4 RIA TEST KIT 06/17/1977
K832164 DIAGNOSTIC PRODUCTS CORP. COAT-A-COUNT FREE T3 RIA KIT 10/27/1983
K812246 DIAGNOSTIC PRODUCTS CORP. COAT-A-COUNT T3 RIA KIT 08/20/1981
K974634 DIAGNOSTIC PRODUCTS CORP. IMMULITE FREE T3 01/02/1998
K914467 DIAGNOSTIC PRODUCTS CORP. MILENIA TOTAL T3 02/06/1992
K895840 DIAGNOSTIC PRODUCTS CORP. MILENIA(TM) TOTAL T4 (MKT41,5) 10/19/1989
K840050 DIAGNOSTIC PRODUCTS CORP. SOPHEIA T3 EIA KIT 03/19/1984
K821725 DIAGNOSTIC REAGENTS, INC. T3 DIAGNOSTIC KIT RIA 06/24/1982
K820251 DIAGNOSTIC REAGENTS, INC. T4 DIAGNOSTIC KIT 05/05/1982
K960550 DIAGNOSTIC SYSTEMS LABORATORIES, INC. ACTIVE T3 RIA 03/06/1996
K971270 DIAGNOSTIC SYSTEMS LABORATORIES, INC. DSL ACTIVE T3 EIA 05/22/1997
K771142 E. R. SQUIBB & SONS, INC. T3 CLASP RIA KIT 07/14/1977
K810211 E. R. SQUIBB & SONS, INC. T3 RIA KIT 02/10/1981
K802883 E. R. SQUIBB & SONS, INC. T3-SQUIBB RIA KIT 12/19/1980
K922771 EASTMAN KODAK COMPANY KODAK AMERLEX MAB FT3 ASSAY 10/14/1992
K810351 ENDOCRINE-METABOLIC CENTER RADIOIMMUNOASSAY, TOTAL TRIIODOTHRONIE 02/23/1981
K832469 FAIRLAKE LABORATORIES T3-RIA SINGLE REAGENT 09/12/1983
K770738 G.D. SEARLE AND CO. REAGENT, T-3 UPTAKE 06/22/1977
K770739 G.D. SEARLE AND CO. SERUM SET, THYROID CONTROL 06/22/1977
K770677 G.D. SEARLE AND CO. T-3 RIA REAGENT SET 05/20/1977
K923258 HERAEUS KULZER, INC. TECHNICON IMMUNO 1 SYSTEM TOTAL TRIIODOTHYRONINE 09/23/1992
K771623 HOFFMANN-LA ROCHE, INC. T3 RIA 09/20/1977
K820763 ICL SCIENTIFIC ENZYM-LINKED T3 04/15/1982
K791663 IMMUCHEM CORP. IMMUCHEM COVALENT COAT SOLID PHASE ASSAY 10/01/1979
K811213 IMMUNO ASSAY CORP. T3 (RIA) KIT 05/29/1981
K834049 IMMUNOTECH CORP. ENDAB T3 01/30/1984
K872191 IMMUNOTECH CORP. IMMUBEAD T3 ENZYME IMMUNOASSAY KIT 08/13/1987
K904820 IMMUNOTECH CORP. MICROZYME T3 ENZYME IMMUNOASSAY KIT 12/18/1990
K791317 IREX CORP. IREX REAL TIME PHASED ARRAY SYSTEM 09/17/1979
K970016 JOHNSON & JOHNSON CLINICAL DIAGNOSTICS, INC. VITROS IMMUNODIAGNOSITCS PRODUCTS-FREE T3 REAGENT PACK (GEM.1020)/FREE T3 CALIBRATORS (GEM.C020) 01/30/1997
K964310 JOHNSON & JOHNSON CLINICAL DIAGNOSTICS, INC. VITROS IMMUNODIAGNOSTICS PRODUCT - TOTAL T3 REAGENT PACK (GEM .101) AND TOTAL CALIIBRATION (GEM.C010) 11/27/1996
K812611 KALLESTAD LABORATORIES, INC. QUANTICOAT NEONATAL 125 T4 RADIOIMMUNO 10/02/1981
K770520 KALLESTAD LABORATORIES, INC. RADIOIMMUNOASSAY, QUANTITIPE 125-I-T3 06/03/1977
K834348 LEECO DIAGNOSTICS, INC. LEECO T3-QUANT DIAG. KIT 02/21/1984
K830808 LEECO DIAGNOSTICS, INC. LEECO T3-RIA DIAGNOSTIC KIT 04/08/1983
K864452 LKB INSTRUMENTS, INC. DELFIA(TM) TRIIODOTHYRONINE (T3) KIT 02/02/1987
K801125 MALLINCKRODT CRITICAL CARE SPAC T3 RIA TEST KIT 06/09/1980
K831064 MEDICAL & SCIENTIFIC DESIGNS, INC. PHASE II T3 RADIOIMMUNOASSAY KIT 05/09/1983
K925436 MEDIX BIOTECH, INC. MEDIX BIOTECH TOTAL T3 ENZYME IMMUNOASSAY TEST KIT 12/28/1992
K904098 MICROGENICS CORP. CEDIA TOTAL T3 ASSAY 09/27/1990
K791375 MICROMEDIC SYSTEMS AUTOPAK 12 T3 RIA TEST DELIVERY SYSTEM 10/11/1979
K790581 MILES LABORATORIES, INC. CHROMATOGRAPHY TUBES 05/15/1979
K771220 MONOBIND T3 RIA TEST SYSTEM 08/04/1977
K971779 MONOBIND TOTAL TRIIODOTHYRONINE(T3) MICROPLATE EIA 06/16/1997
K926345 MONOBIND TRIODOTHYRONINE (TC) COATED TUBE RIA 02/25/1993
K931600 NICHOLS INSTITUTE CHEMILUMINESCENCE FREE T3 IMMUNOASSAY 09/08/1993
K965058 NICHOLS INSTITUTE DIAGNOSTICS NICHOLS ADVANTAGE CHEMILUMINESCENCE FREE T3 KIT 03/11/1997
K923015 NICHOLS INSTITUTE DIAGNOSTICS TOTAL T3 CHEMILUMINESCENCE ASSAY 09/02/1992
K780292 NUCLEAR DIAGNOSTICS, INC. TRIA-PEG RIA DIAG. KIT 03/02/1978
K772177 NUCLEAR MEDICAL LABORATORIES, INC. TRI-TAB-RIA 12/22/1977
K944808 ORGANON TEKNIKA CORP. IMX T3 ASSAY 12/09/1994
K781481 ORTHO DIAGNOSTICS, INC. ORTHO*T-3 RIA (PEG) KIT 09/27/1978
K760078 OXFORD LABORATORIES, INC. REAGENT, RIA TRIIODOTHYRONINE T3 (#200) 07/20/1976
K905410 PB DIAGNOSTIC SYSTEMS, INC. OPUS T3 TEST SYSTEM 02/04/1991
K803180 PCL-RIA, INC. 1-125 LABELED TRIIODOTHYRONINE(T3) 01/09/1981
K781284 PCL-RIA, INC. RABBIT ANTIBODY TO HUMAN T3 08/31/1978
K812666 PCL-RIA, INC. THYROXINE (T4) 125I 10/02/1981
K883810 PHARMACIA, INC. DELFIA TRIIODOTHYRONINE (T3) KIT 12/02/1988
K792539 RADIOIMMUNOASSAY, INC. TRIIODOTHYRONINE RIA SYSTEM 01/16/1980
K001607 REPROMEDIX CORP. REPROBEAD T3 ENZYME IMMUNOASSAY REAGENT KIT (CATALOG# 104) 10/05/2000
K852537 RIA DIAGNOSTICS T-3 RIASSAY 08/12/1985
K932608 ROCHE DIAGNOSTIC SYSTEMS, INC. COBAS(R) CORE T3 EIA 12/03/1993
K881214 SCLAVO, INC. IMMPULSE T, ASSAY REAGENTS 05/27/1988
K880388 SERONO DIAGNOSTICS, INC. T3 SEROZYME ENZYMEIMMUNOASSAY KIT, MAG SOLID PHASE 03/03/1988
K910737 SERONO-BAKER DIAGNOSTICS, INC. SRI T3 IMMOENZYMETRIC ASSAY 05/01/1991
K952557 SIGMA DIAGNOSTICS, INC. TOTAL T-3 FPIA REAGENT SET, TOTAL T-3 FPIA CALIBRATORS 01/24/1996
K760057 SMITH KLINE DIAGNOSTICS, INC. TEST, RIA, TRIODOTHYRONINE 09/13/1976
K833853 SYNCOR INTL. CORP. T3 RIA 02/04/1984
K923571 SYVA CO. VISTA TRIIODOTHYRONINE ASSAY 10/15/1992
K801843 TECHNIA DIAGNOSTICS LTD. T3(125) RADIOIMMUNOASSAY KIT 09/16/1980
K810798 TECHNICON INSTRUMENTS CORP. TECHNICON STAR SYSTEM T3 RIA METHOD 04/07/1981
K897001 TOSOH CORP. TOSOH AIA-PACK T3 03/09/1990
K991252 TOSOH MEDICS, INC. AIA-PACK FT3 ASSAY 05/11/1999
K963687 TOSOH MEDICS, INC. AIA-PACK FT3 ASSAY 11/08/1996
K936229 TOSOH MEDICS, INC. AIA-PACK TT3 ASSAY 07/14/1994
K761305 UNION CARBIDE CORP. CENTRIA T3 RIA 12/30/1976
K961236 UNITED BIOTECH, INC. UBI MAGIWEL TRIIODOTHYRONINE(T3) QUANTITATIVE 05/30/1996
K790908 VENTREX LABORATORIES, INC. RIA, TEST SET CENTRIA T3 06/27/1979
K791588 VENTREX LABORATORIES, INC. VENTRE/SEP T3 TEST SET 09/27/1979
K853703 VXR, INC. VENTREZYME T3 IMMUNOASSAY T3 10/04/1985


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