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 |
| K223405 | Beckman Coulter, Inc. | Access Testosterone | 01/13/2023 |
| 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 |
| 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 |
| K971823 | DIAGNOSTIC SYSTEMS LABORATORIES, INC. | ACTIVE TESTOSTERONE EIA (DSL-10-4000) | 06/16/1997 |
| 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 |
| K201908 | DiaSorin Inc. | LIAISON Testosterone xt | 10/15/2020 |
| 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 |
| K190121 | Immunodiagnostic Systems Ltd. | IDS SHBG | 06/17/2019 |
| K191350 | Immunotech s.r.o. | ACTIVE« Free Testosterone RIA | 12/20/2019 |
| K973900 | KMI DIAGNOSTICS, INC. | TESTOTERONE ELISA | 02/24/1998 |
| K181017 | Monobind Inc. | Free Testosterone AccuBind ELISA Test System | 07/20/2018 |
| K153577 | NanoEnTek USA Inc. | FREND Testosterone Test System | 10/14/2016 |
| 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 |
| K211685 | Roche Diagnostics | Elecsys Testosterone II | 05/06/2022 |
| 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 |
| 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 |
| 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 |
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