FDA 510(k) Applications for Medical Device Product Code "CDX"
(Radioimmunoassay, Total Thyroxine)

FDA 510(k) Number Applicant Device Name Decision Date
K925110 ABBOTT LABORATORIES ABBOTT IMX T4 01/26/1993
K925109 ABBOTT LABORATORIES ABBOTT TDX/TDXFLX TT4 01/04/1993
K934384 ABBOTT LABORATORIES AXSYM(TM) TOTAL T4 06/21/1994
K771309 ABBOTT LABORATORIES RIA FOR TOTAL THYROXINE 08/03/1977
K792188 ABBOTT LABORATORIES TETRABEAD - 125 T4 SOLID PHASE DIAG. KIT 11/27/1979
K770474 ABBOTT LABORATORIES THYROSCREEN TM T4 DIAGNOSTIC KIT 04/28/1977
K803046 AMERICAN DADE IMMU-TRACE T4 RIA PROCEDURE 01/02/1981
K860421 AMERICAN DADE STRAT TOTAL THYROXINE FLUOROMET ENZYME IMMUNOASSAY 02/11/1986
K802469 AMERICAN DIAGNOSTIC CORP. T4 RADIOIMMUNOASSAY KIT 11/12/1980
K800300 AMERSHAM CORP. AMERLEX T-4 RIA KIT 03/05/1980
K821554 AMF BIOLOGICAL AND DIAGNOSTICS CO. ZETAPHASE T4 RADIOIMMUNOASSAY DIAG. KIT 06/25/1982
K933426 BAXTER DIAGNOSTICS, INC. STRATUS(R) TOTAL THYROXINE(T4) FLUOR ENZYME IMMUNO 08/26/1993
K901475 BAXTER HEALTHCARE CORP. CLINICAL ASSAYS(TM) GAMMACOAT(TM) M [125I] T4 06/20/1990
K864560 BD BECTON DICKINSON VACUTAINER SYSTEMS PREANALYTIC IQ T4 IMMUNOASSAY 12/16/1986
K781182 BD BECTON DICKINSON VACUTAINER SYSTEMS PREANALYTIC MICRO THYROXINE REAGENT SYSTEM 08/14/1978
K823265 BD BECTON DICKINSON VACUTAINER SYSTEMS PREANALYTIC MONOCLONAL ANTIBODY T4 RADIO-KIT 12/09/1982
K770733 BD BECTON DICKINSON VACUTAINER SYSTEMS PREANALYTIC REAGENT SYSTEM, THYROXINE, ARIA 06/24/1977
K772330 BD BECTON DICKINSON VACUTAINER SYSTEMS PREANALYTIC T4 RIA KIT 01/12/1978
K904816 BD BECTON DICKINSON VACUTAINER SYSTEMS PREANALYTIC THYROXINE MONOCLONAL ANTIBODY SOLID PHASE RADIOIMM 01/17/1991
K931295 BECTON DICKINSON ADVANCED DIAGNOSTICS IQ TT4 ASSAY 07/20/1993
K926563 BIO-CHEM LABORATORY SYSTEMS, INC. AUTOBEAD(TM) T4 ENZYME IMMUNOASSAY TEST KIT 03/18/1993
K811787 BIO-RAD QUANTAPHASE T-4 RIA 07/10/1981
K771135 BIO-RAD QUANTIMUNE NEONATAL & THYROXINE RIA 07/14/1977
K790576 BIO-RAD QUANTIMUNE T-4 FIA 07/30/1979
K760135 BIO-RAD TEST, RA, QUANTA-COUNT T-4 07/20/1976
K823004 BIOCLINICAL GROUP BIO MAG TOTAL T4 RADIOIMMUNOASSAY KIT 11/05/1982
K821101 BIOCLINICAL GROUP TOTAL RADIOIMMUNOASSAY KIT 05/05/1982
K771414 BIOMEDICAL LABS., INC. T4 BY RIA DIAG. KIT 09/22/1977
K834023 BIOSAN LABORATORIES, INC. BIO-SCIENCE LABORATORIES T4 REAGENT 01/24/1984
K961490 BOEHRINGER MANNHEIM CORP. ELECSYS T4 ASSAY 06/13/1996
K800203 BOEHRINGER MANNHEIM CORP. RIA PHASE T4 03/19/1980
K791231 BURROUGHS WELLCOME CO. DAC-CEL T4 09/04/1979
K801105 CALBIOCHEM-BEHRING CORP. THYROXINE RADIOIMMUNOASSAY KIT 06/09/1980
K870573 CAMBRIDGE MEDICAL TECHNOLOGY T4 NO SPIN(TM) COATED TUBE RADIOIMMUNOASSAY KIT 04/22/1987
K905532 CIBA CORNING DIAGNOSTICS CORP. CIBA CORNING ACS T4 IMMUNOASSAY 01/15/1991
K872286 CIBA CORNING DIAGNOSTICS CORP. CIBA CORNING MAGIC LITE FT4 IMMUNOASSAY 07/21/1987
K870965 CIBA CORNING DIAGNOSTICS CORP. CIBA CORNING MAGIC(R) LITE T4 IMMUNOASSAY 05/14/1987
K780854 CLINICAL ASSAYS, INC. IN VITRO NEONATAL T4 07/27/1978
K781235 CLINICAL ASSAYS, INC. IV VITRO GAMMADAB T4 RIA KIT 08/14/1978
K782109 CLINICAL ASSAYS, INC. RIA KIT, GAMMACOAT 01/26/1979
K780707 CLINICAL BIORESEARCH T4-RIA KIT 06/14/1978
K761272 CLINICAL DIAGNOSTICS, INC. CENTRIA T4 RIA 03/16/1977
K771415 CLINICAL IMMUNO-DIAGNOSTICS RIA FOR SERUM THYROXINE 01/05/1978
K831533 CORNING MEDICAL & SCIENTIFIC MAGIC T4 125I RADIOIMMUNOASSAY 06/30/1983
K771609 CORNING MEDICAL & SCIENTIFIC PEDIATRIC THYROXINE TEST SYS. T4 12/20/1977
K780401 COULTER ELECTRONICS, INC. THYRO-ZYME-T4 ASSAY KIT 04/24/1978
K874623 CYBERFLUOR, INC. FIAGEN(TM) THYROXINE (T4), CATALOGUE #101-101 02/16/1988
K761282 DADE, BAXTER TRAVENOL DIAGNOSTICS, INC. DATA-TOPE T4 RIA PROCEDURE 12/30/1976
K831107 DIAGNOSTIC PRODUCTS CORP. COAT-A-COUNT NEONATAL T4 KIT RIA KIT 05/18/1983
K811315 DIAGNOSTIC PRODUCTS CORP. COAT-A-COUNT T4 RIA KIT 05/27/1981
K912541 DIAGNOSTIC PRODUCTS CORP. MILENIA TOTAL T4, CATALOG: MKT41,5 08/12/1991
K770241 DIAGNOSTIC PRODUCTS CORP. NEONATAL T4 RIA KIT 02/14/1977
K954312 DIAGNOSTIC SYSTEMS LABORATORIES, INC. ACTIVE THYROXINE RIA 10/07/1995
K802456 E. R. SQUIBB & SONS, INC. T4-SQUIBB RIA KIT 10/31/1980
K790477 E. R. SQUIBB & SONS, INC. TY RIA KIT, AUTOMATED ASSAY SYSTEM 04/26/1979
K800187 ENDOCRINE-METABOLIC CENTER EMC-M-175, THYROXINE - 100 TUBES 02/13/1980
K832468 FAIRLAKE LABORATORIES T4-RIA SINGLE REAGENT 09/12/1983
K770737 G.D. SEARLE AND CO. REAGENT SET, T-4, CPB 06/22/1977
K770676 G.D. SEARLE AND CO. T-4 RIA REAGENT SET 05/20/1977
K922945 HERAEUS KULZER, INC. TECHNICON DAX SYSTEM THYROXINE (T4) METHOD 10/14/1992
K791664 IMMUCHEM CORP. IMMUCHEM COVALENT COAT SOLID PHASE ASSAY 09/27/1979
K833745 IMMUNO ASSAY CORP. RIACOAT T-4 01/04/1984
K810811 IMMUNO ASSAY CORP. T4 RIA KIT 04/07/1981
K821141 IMMUNOTECH CORP. ENDAB T4 ENZYME IMMUNOASSAY KIT 05/13/1982
K902922 IMMUNOTECH CORP. MICROZYME T4 ENZYME IMMUNOASSAY KIT 07/27/1990
K915235 INCSTAR CORP. CLINICAL ASSAYS GAMMA COAT FREE T4 RADIOIMM. KIT 01/28/1992
K811070 INTL. IMMUNOASSAY LABORATORIES, INC. 125 I-T4 RIA TEST KIT 04/29/1981
K760227 KALLESTAD LABORATORIES, INC. RADIOIMMUNOASSAY 07/26/1976
K822399 LEECO DIAGNOSTICS, INC. LEECO T4 QUANT DIAGNOSTICS TEST KIT 09/13/1982
K871303 LKB INSTRUMENTS, INC. DELFIA(TM) THYROXINE (T4) KIT 06/17/1987
K911985 LONDON DIAGNOSTICS, INC. LUMATAG T4 CHEMILUMINESCENCE ASSAY 08/02/1991
K820725 MALLINCKRODT CRITICAL CARE SPAC T4 RIA TEST KIT 06/01/1982
K770156 MALLINCKRODT CRITICAL CARE SPAC TM T4 RIA KIT 02/07/1977
K772064 MEDCOM DIAGNOSTICS, INC. THYRODOT-4 ANTISERA LYOPHOLIZED 11/14/1977
K830642 MEDICAL & SCIENTIFIC DESIGNS, INC. PHASE THYROXINE RADIOIMMUNOASSAY KIT 04/05/1983
K771606 MELOY LABORATORIES, INC. IMMUNOSPOT NEONATAL T4 TEST 09/15/1977
K790907 MICROMEDIC SYSTEMS AUTOPAK TEST DELIVERY SYSTEM 06/27/1979
K871008 MICROMEDIC SYSTEMS MICROMEDIC NEONATAL T4 KIT 05/26/1987
K861320 MICROMEDIC SYSTEMS MMS T4 RIA KIT 04/24/1986
K790665 MICROMEDIC SYSTEMS NEONATAL TY AUTOPAK TEST DELIVERY SYSTEM 05/15/1979
K800169 MILES LABORATORIES, INC. AMES RIALYZE - CHROMATOGRAPHY TUBES 02/13/1980
K772014 MILES LABORATORIES, INC. AMES T-4 STRIP TEST 11/02/1977
K781181 MILES LABORATORIES, INC. CLINIRIA TOTAL T-4 (RIA) TEST 08/14/1978
K760572 MILES LABORATORIES, INC. SERALUTE 11/23/1976
K771221 MONOBIND T4 RIA TEST SYSTEM 08/04/1977
K921935 MONOBIND THYROXINE (T4) COATED TUBE RIA 07/07/1992
K781222 NEOMETRICS, INC. ACCUSCREEN T4 11/08/1978
K901939 NEOMETRICS, INC. NEOCOAT T4 05/31/1990
K792599 NUCLEAR DIAGNOSTICS, INC. "TIPSEP-T4(RIA) T4 RADIOIMMUNOASSAY" 01/16/1980
K780644 NUCLEAR DIAGNOSTICS, INC. RADIOASSAY FOR TOTAL SERUM THYROXINE 04/28/1978
K780423 NUCLEAR DIAGNOSTICS, INC. STIKSEP-T4 RIA KIT 03/30/1978
K823053 NUCLEAR MEDICAL LABORATORIES, INC. NML-TETRA-TUBE RIA 11/10/1982
K780308 ORGANON, INC. OREIA-T4 04/12/1978
K781483 ORTHO DIAGNOSTICS, INC. ORTHO*T-4 RIA (PEG) KIT 09/27/1978
K760079 OXFORD LABORATORIES, INC. REAGENT, THYROXINE T4 (#210) 07/20/1976
K854324 PANTEX, DIV. BIO-ANALYSIS, INC. PANCOAT T4 COATED TUBE RADIOIMMUNOASSAY KIT 12/05/1985
K840852 PARAGON DIAGNOSTICS, INC. IMMPULSE T4 ASSAY REAGENTS 04/18/1984
K772096 PCL-RIA, INC. IN VITRO DIAGNOSTIC REAGENT 11/22/1977
K780050 PCL-RIA, INC. THYROXINE STDS. IN HUMAN SERUM 02/13/1978
K820886 PCL-RIA, INC. THYROXINE T4 KIT 04/16/1982
K883559 PHARMACIA, INC. DELFIA THYROXINE (T4) KIT 12/14/1988
K780672 RADIOIMMUNOASSAY, INC. 125 I-T4 RIA REAGENT 06/06/1978
K854798 RIA DIAGNOSTICS T-4 RIASSAY 01/15/1986
K875081 SCLAVO, INC. IMMPULSE T4 ASSAY REAGENTS 02/11/1988
K782103 SERONO LABORATORIES, INC. RIA KIT, NEONATAL T4 01/17/1979
K932980 SIGMA DIAGNOSTICS, INC. TOTAL T4 FPIA REAGENT SET/CALIBRATOR #T-1039,T-116 10/18/1993
K770726 SQUIBB & SONS, INC. RIA KIT, T4 CLASP 04/28/1977
K833850 SYNCOR INTL. CORP. T4 RIA 01/18/1984
K780219 SYVA CO. ANALYSIS SYS., EMIT MAN. THYROXINE ASSAY 03/03/1978
K772170 SYVA CO. EMIT CENTRIFICHEM THYROXINE ASSAY 12/22/1977
K780639 SYVA CO. EMIT CENTRIFICHEM THYROXINE ASSAY 05/03/1978
K780121 SYVA CO. REAGENTS, MANUEAL, ASSAY, THYROXINE 03/17/1978
K920766 TECH-CO, INC. T4 EIA BEAD ASSAY 04/17/1992
K790495 TECHNIA DIAGNOSTICS LTD. THYROXINE RIA KIT 05/03/1979
K800385 TECHNICON INSTRUMENTS CORP. ANALYTE T4-THYROXINE 03/19/1980
K894575 TECHNICON INSTRUMENTS CORP. TECHNICON RA SYSTEM THYROXINE T4 METHOD 10/04/1989
K770940 THE DOW CHEMICAL CO. TOTAL THYROXINE (RIA) REAGENT SET 06/22/1977
K790800 VENTREX LABORATORIES, INC. CENTRIA T4 RIA TEST SET 06/15/1979
K791368 VENTREX LABORATORIES, INC. VENTRE/SEP T4 TEST SET 09/17/1979
K943416 WALLAC OY DELFIA NEONATAL THYROXINE KIT 03/10/1995
K802573 WORTHINGTON DIAGNOSTIC SYSTEMS SERUM T4 BY ENZYME IMMUNOASSAY 11/24/1980


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