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 |
| K190121 | Immunodiagnostic Systems Ltd. | IDS SHBG | 06/17/2019 |
| K191350 | Immunotech s.r.o. | ACTIVE« Free Testosterone RIA | 12/20/2019 |
| 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 |
| K182521 | Qualigen, Inc. | FastPack IP Sex Hormone Binding Globulin Immunoassay | 01/29/2019 |
| 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 |
| K191533 | Siemens Healthcare Diagnostics Inc. | ADVIA Centaur Testosterone II (TSTII), ADVIA Centaur SHBG | 08/28/2019 |
| 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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