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
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
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
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
K133491 SIEMENS HEALTHCARE DIAGNOSTICS INC. ADVIA CENTAUR TESTOSTERONE (TSTO) 02/21/2014
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 7/2/2015
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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