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 |
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 |
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 |