FDA 510(k) Applications for Medical Device Product Code "CDZ"
(Radioimmunoassay, Testosterones And Dihydrotestosterone)

FDA 510(k) Number Applicant Device Name Decision Date
K983212 ABBOTT LABORATORIES ABBOTT ARCHITECT TESTOSTERONE 11/18/1998
K152155 Abbott Laboratories ARCHITECT 2nd Generation Testosterone 12/17/2015
K120009 ABBOTT LABORATORIES TESTOSTERONE TEST SYSTEM; CALIBRATOR; AND QUALITY CONTROL MATERIAL (ASSAYED AND UNASSAYED) 09/11/2012
K041866 AXIS-SHIELD DIAGNOSTICS, LTD. ABBOTT AXSYM TESTOSTERONE MICROPARTICLE ENZYME IMMUNOASSAY (MEIA) 09/29/2004
K963080 BAYER CORP. TESTOSTERONEE ASSAY FOR THE TECHNICON IMMUNO 1 SYSTEM (IN-VITRO DIAGNOSTIC SYSTEM) 09/27/1996
K083867 BECKMAN COULTER, INC. ACCESS SEX HORMONE BINDING GLOBULIN REAGENT, ACCESS SEX HORMONE BINDING GLOBULIN CALIBRATORS AND ACCESS SEX HORMONE BIND 08/27/2009
K001935 BECKMAN COULTER, INC. ACCESS TESTOSTERONE REAGENTS FOR USE ON THE ACCESS IMMUNOASSAY ANALYZER, MODELS 33560, 33565 08/22/2000
K002294 BIOCHECK, INC. BIOCHECK TESTOSTERONE EIA, MODEL BC-1115 10/02/2000
K955102 BIOCHEM IMMUNOSYSTEMS (U.S.), INC. BIODATA TESTOSTERONE MAIA KIT 06/24/1996
K060818 BIOKIT S.A. ARCHITECT SHBG REAGENT KIT, ARCHITECT SHBG CALIBRATOR KIT, AND ARCHITECT SHBG CONTROL KIT WITH MODELS, 8K26-25, 8K26-01 01/23/2007
K152185 BIOKIT, S.A. ARCHITECT SHBG 02/11/2016
K021326 BIOMERIEUX, INC. VIDAS TESTOSTERONE (TES), MODEL 30 418 07/18/2002
K964889 BOEHRINGER MANNHEIM CORP. ELECSYS TESTOSTERONE ASSAY 03/18/1997
K841042 CAMBRIDGE MEDICAL TECHNOLOGY MATCHED COMPONENT SET RADIOIMMUNOASSAY 04/19/1984
K860130 CAMBRIDGE MEDICAL TECHNOLOGY TESTOSTERONE COATED TUBES RADIOIMMUNOASSAY KIT 02/19/1986
K790007 CAMBRIDGE NUCLEAR CORP. I TESTOTERONE 02/26/1979
K934562 CIBA CORNING DIAGNOSTICS CORP. CIBA CORNING ACS TESTOSTERONE IMMUNOASSAY 12/10/1993
K840187 CORNING MEDICAL & SCIENTIFIC IMMOPHASE DTESTO RADIOIMMUNOASSAY- 03/23/1984
K802661 DAMON CORP. LIQUISOL TESTOSTERONE RADIOIMM. TEST KIT 12/10/1980
K844423 DIAGNOSTIC PRODUCTS CORP. COAT-A-COUNT FREE TESTOSTERONE KIT & COMPONENTS 02/27/1985
K831342 DIAGNOSTIC PRODUCTS CORP. COAT-A-COUNT NO-EXTRACTION TESTOSTERONE 06/02/1983
K813401 DIAGNOSTIC PRODUCTS CORP. COAT-A-COUNT TESTOSTERONE RIA KIT 12/22/1981
K941797 DIAGNOSTIC PRODUCTS CORP. IMMULITE SHBG 10/31/1994
K955440 DIAGNOSTIC PRODUCTS CORP. IMMULITE SHBG (MODIFICATION) 12/21/1995
K955870 DIAGNOSTIC PRODUCTS CORP. IMMULITE TOTAL TESTOSTERONE 02/06/1996
K032881 DIAGNOSTIC PRODUCTS CORP. IMMULITE/IMMULITE 1000 TOTAL TESTOSTERONE AND IMMULITE 2000 TOTAL TESTOSTERONE 10/10/2003
K883267 DIAGNOSTIC PRODUCTS CORP. IRMA-COUNT (TM) SHBG (SEX HORMORNE BIND GLOBULIN) 10/31/1988
K772191 DIAGNOSTIC PRODUCTS CORP. TESTOSTERONE RIA KIT (125I) 01/12/1978
K952281 DIAGNOSTIC SYSTEMS LABORATORIES, INC. ACTIVE FREE TESTOSTERONE RIA 07/17/1995
K971823 DIAGNOSTIC SYSTEMS LABORATORIES, INC. ACTIVE TESTOSTERONE EIA (DSL-10-4000) 06/16/1997
K915823 DIAGNOSTIC SYSTEMS LABORATORIES, INC. DSL ACTIVE SHBG (DSL 7400) 03/17/1992
K854671 DIAGNOSTIC SYSTEMS LABORATORIES, INC. DSL ACTIVE TESTOSTERONE RIA (DSL #4000) 12/19/1985
K854674 DIAGNOSTIC SYSTEMS LABORATORIES, INC. DSL ANDROSTENDIONE RIA (DSL #4200) 12/19/1985
K904100 DIAGNOSTIC SYSTEMS LABORATORIES, INC. DSL SEX HORMONE BINDING GLOBULIN (SHBG) (DSL 6300) 10/15/1990
K001086 DIAGNOSTIC SYSTEMS LABORATORIES, INC. FREE TESTOSTERONE ENZYME IMMUNOASSAY, MODEL DSL-10-4900 05/18/2000
K030730 DIAGNOSTICS BIOCHEM CANADA, INC. FREE TESTOSTERONE ENZYMEIMMUNOASSAY (EIA) KIT 08/18/2003
K014120 DIAGNOSTICS BIOCHEM CANADA, INC. TESTOSTERONE BY ENZYMEIMMUNOASSAY (EIA) 02/08/2002
K122793 DIASORIN, INC. LIAISON TESTOSTERONE; LIAISON TESTOSTERONE CONTROL SET 01/25/2013
K000043 DRG INTL., INC. DRG AURICA ELISA TESTOSTERONE KIT 04/17/2000
K052649 DRG INTL., INC. DRG SLV TESTOSTERONE ELISA TEST 01/27/2006
K861679 FARMOS GROUP LTD. SHBG IRMA KIT 03/13/1987
K811536 IMMUCHEM CORP. DIRECT TESTOSTERONE RIA 06/18/1981
K801666 IMMUCHEM CORP. TESTOSTERONE KIT 08/27/1980
K915570 INCSTAR CORP. GAMMA COAT ASSAY TESTOSTERONE RADIOIMMUNOASSAY KIT 01/27/1992
K973900 KMI DIAGNOSTICS, INC. TESTOTERONE ELISA 02/24/1998
K813059 LEECO DIAGNOSTICS, INC. LEECO TESTO-QUANT DIAG. KIT 11/16/1981
K803001 LEECO DIAGNOSTICS, INC. LEECO TESTO-QUANT DIAGNOSTIC KIT 01/02/1981
K830512 LEECO DIAGNOSTICS, INC. LEECO TESTOSTERONE DIAGNOSTIC KIT 04/05/1983
K860003 LEECO DIAGNOSTICS, INC. LEECO TESTOSTERONE DIAGNOSTIC KIT 03/17/1986
K181017 Monobind Inc. Free Testosterone AccuBind ELISA Test System 07/20/2018
K153577 NanoEnTek USA Inc. FREND Testosterone Test System 10/14/2016
K800921 NORDICLAB INTL. NORDICLAB TESTOSTERONE RIA TEST 05/14/1980
K951685 ORGANON TEKNIKA CORP. AURAFLEX TESTOSTERONE CALIBRATOR PACK 11/14/1995
K853865 PANTEX, DIV. BIO-ANALYSIS, INC. PANTEX DIRECT TESTOSTERONE COATED TUBE RADIOIMMUNO 10/15/1985
K862483 PANTEX, DIV. BIO-ANALYSIS, INC. PANTEX FTE FREE TESTOSTERONE RADIOIMMUNOASSAY KIT 01/14/1987
K884809 PHARMACIA, INC. DELFIA SHBG KIT 03/08/1989
K101388 Qualigen, Inc. FASTPACK TESTO IMMUNOASSAY 02/18/2011
K021972 Qualigen, Inc. FASTPACK TOTAL TESTOSTERONE IMMUNOASSAY 08/21/2002
K791999 RADIOASSAY SYSTEMS LABORATORIES, INC. (125I) TESTOSTERONE KIT 10/30/1979
K802135 RADIOIMMUNOASSAY, INC. TESTOSTERONE RADIOIMMUNOASSY KIT 10/10/1980
K102814 Roche Diagnostics ELECYSYS SHBG 01/20/2011
K031717 ROCHE DIAGNOSTICS CORP. ELECSYS SHBG IMMUNOASSAY 08/05/2003
K093421 ROCHE DIAGNOSTICS CORP. ELECSYS TESTOSTERONE II IMMUNOASSAY 04/23/2010
K915164 SERONO-BAKER DIAGNOSTICS, INC. SRI TESTOSTERONE ENZYME IMMUNOASSAY 03/02/1992
K924257 SERONO-BAKER DIAGNOSTICS, INC. TESTOSTERONE SEROZYME(TM) ENZYME IMMUNOASSAY 11/30/1992
K091867 SIEMENS HEALTHCARE DIAGNOSTICS ADVIA CENTAUR SHBG READYPACK, LOW AND HIGH CALIBRATORS AND MASTER CURVE MATERIAL, MODELS 06520781, 04819274 AND 06520773 01/14/2010
K151986 SIEMENS HEALTHCARE DIAGNOSTICS INC. ADVA Centaur Testosterone II (TSTII), ADVA Centaur Testosterone II (TSTII) Master Curve Material, ADVIA Centaur SHBG, ADVIA Centaur SHBG Calibrator, ADVIA Centaur SHBG Master Curve Material 06/29/2016
K133491 Siemens Healthcare Diagnostics Inc. ADVIA CENTAUR TESTOSTERONE (TSTO) 02/21/2014
K151529 SIEMENS HEALTHCARE DIAGNOSTICS, INC. Dimension Vista LOCI Total Testosterone Flex reagent cartridge, Dimension Vista Testosterone Calibrator 02/11/2016
K800776 SORIN BIOMEDICA, FIAT, USA, INC. TESTOK-125 04/21/1980
K841948 SORIN BIOMEDICA, FIAT, USA, INC. TESTOSTERONE DIRECT RADIOIMMUNOASSAY 06/25/1984
K780792 THE UPJOHN CO. TESTOSTERONE RADIOIMMUNOASSAY KIT 125I 06/13/1978
K143075 TOSOH BIOSCIENCE, INC. ST AIA-PACK SHBG, ST AIA-PACK SHBG Calibrator Set 07/02/2015
K023091 TOSOH MEDICS, INC. ST AIA-PACK TESTOSTERONE ASSAY 12/17/2002
K905247 VENTREX LABORATORIES, INC. SHBG IRMA KIT 01/17/1991
K940449 WALLAC OY DELFIA SHBG KIT 09/06/1994
K932951 WALLAC OY DELFIA TESTTOSTERONE KIT 08/03/1993
K802728 WIEN LABORATORIES, INC. 125I-TESTOSTERONE TEST SET 12/11/1980
K912850 WIEN LABORATORIES, INC. SHBG 08/12/1991


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