FDA 510(k) Applications for Medical Device Product Code "CGJ"
(Radioimmunoassay, Follicle-Stimulating Hormone)

FDA 510(k) Number Applicant Device Name Decision Date
K935612 ABBOTT LABORATORIES AXSYM FOLLICLE STIMULATING HORMONE (FSH) 06/21/1994
K810381 ABBOTT LABORATORIES HTSH RIABEAD DIAGNOSTIC KIT 02/26/1981
K890135 ABBOTT LABORATORIES IMX FOLLICLE STIMULATING HORMONE (FSH) 02/10/1989
K041165 ACON LABORATORIES, INC. FSH MENOPAUSE PREDICTOR TEST 06/17/2004
K854651 AMERICAN DADE PARAAMAX CHLORIDE DETERMINATION BY ISE 12/13/1985
K873051 AMERICAN DADE STRATUS(R) HFSH FLUOROMETRIC ENZYME IMMUNOASSAY 10/20/1987
K820754 AMERSHAM CORP. AMERLEX ESH KIT 04/15/1982
K851361 AMERSHAM CORP. AMERLEX-M FOLLICLE STIMULATING HORMONE(FSH)RADIOIM 05/07/1985
K881142 AMERSHAM CORP. AMERLITE FSH ASSAY, LAN.0077/2077 240 AND 144 TEST 07/21/1988
K760373 AMERSHAM CORP. RADIOASSAY KIT, IM.72 FSH 11/01/1976
K905592 BD BECTON DICKINSON VACUTAINER SYSTEMS PREANALYTIC AFFINITY FSH TEST SYSTEM 12/27/1990
K895108 BD BECTON DICKINSON VACUTAINER SYSTEMS PREANALYTIC FOLLICLE STIMULATING HORMONE MAB SOLID PHASE COM. 10/23/1989
K883305 BINAX, INC. BINAX FSH IRMA TEST KIT, IMMUNORADIOMETRIC ASSAY 10/06/1988
K920917 BIO CLINIC CO. ELISA TUBE FSH TEST KIT ENZYME LINKED IMMUN. ASSAY 03/26/1992
K791836 BIO-RAD QUANTIMUNE HFSH RIA 10/01/1979
K831742 BIO-RAD QUANTIMUNE HFSH RIA HUMAN FOLLICLE- 07/18/1983
K940005 BIO-RAD LABORATORIES, INC. ACCESS HUMAN FOLLICLE STIMULATING HORMONE ASSAY 03/03/1994
K904405 BIOCLONE AUSTRALIA PTY LTD. BIOCLONES ELEGANCE FSH ELISA KIT 10/26/1990
K921746 BIOMERIEUX VITEK, INC. VITEK IMMUNODIAGNOSTIC ASSAY SYSTEM 06/16/1992
K964693 BOEHRINGER MANNHEIM CORP. ELECSYS FSH ASSAY 12/16/1996
K900763 BOEHRINGER MANNHEIM CORP. ENZYMUN TEST(R) FSH 03/15/1990
K862439 BOOTS-CELLTECH DIAGNOSTICS, INC. SUCROSEP FOLLICLE STIMULATING HORMONE (FSH) IRMA 08/19/1986
K780870 CALBIOCHEM-BEHRING CORP. RIA SYSTEM FOR HUMAN F-S HORMONE 06/22/1978
K904649 CIBA CORNING DIAGNOSTICS CORP. CIBA CORNING ACS FSH IMMUNOASSAY 11/20/1990
K884687 CIBA CORNING DIAGNOSTICS CORP. CIBA CORNING MAGIC LITE FSH IMMUNOASSAY 12/06/1988
K921704 CIRRUS DIAGNOSTICS, INC. IMMULITE(R) FSH 06/09/1992
K792063 CIS RADIOPHARMACEUTICALS, INC. FOLLICLE STIMULATING HORMONE (FSH) KIT 11/20/1979
K823379 CLINETICS CORP. 125-I FSH RADIOIMMUNOASSAY KIT 12/22/1982
K844066 CLINETICS CORP. COTROPIN STIMULATANEOUS 57 CO-LH 125I I-FSH 01/18/1985
K821611 CLINICAL ASSAYS, INC. GAMMADAB [125] FSH RADIOIMMUNAY KIT 06/24/1982
K822227 CORNING MEDICAL & SCIENTIFIC IMMO PHASE FSH RADIOIMMUNOASSAY 08/16/1982
K884708 CYBERFLUOR, INC. FIAGEN HFSH TIME-RESOLVED FLUOROIMMUNOASSAY KIT 01/17/1989
K893976 DIAGNOSTIC PRODUCTS CORP. COAT-A-COUNT (TM) FSH IRMA 08/17/1989
K883745 DIAGNOSTIC PRODUCTS CORP. IRMA-COUNT(TM) FSH W/MONOCLONAL ANTIBODIES 11/30/1988
K895005 DIAGNOSTIC PRODUCTS CORP. MILENIA(TM) FSH (MKFS1,5) 10/31/1989
K962118 DIAGNOSTIC SYSTEMS LABORATORIES, INC. DSL ACTIVE FSH IRMA 09/09/1996
K941221 DUPONT MEDICAL PRODUCTS DUPONT ACA PLUS IMMUNOASSAY SYSTEM FOLLICLE STIMULATING HORMONE 07/20/1994
K030058 EARLY DETECT, INC. EARLYDETECT MENOPAUSE TEST FOR FSH 07/30/2003
K811993 ENDOCRINE-METABOLIC CENTER RADIOIMMUNOASSAY, FOLLICLE STIMULATING 08/03/1981
K843930 EURO-DIAGNOSTICS BV IRMA IMMUNORADIOMETRIC ASSAY-FSH 125I 10/30/1984
K002450 GENUA 1944, INC. GENUA MENOPAUSE MONITOR TEST KIT 01/12/2001
K870520 HYBRITECH, INC. TANDEM(R)-M FSH IMMUNOENZYMETRIC ASSAY 03/10/1987
K894761 HYBRITECH, INC. TANDEM-E FSH IMMUNOENZYMETRIC ASSAY KIT 09/13/1989
K922376 ICN BIOMEDICALS, INC. ICN BIOMEDICALS IMMUCHEM(TM) FSH-MW ELISA KIT 10/05/1992
K871317 IMMUCHEM CORP. FOLLICLE STIMULATING HORMONE (HFSH) 05/20/1987
K811905 IMMUNALYSIS CORPORATION FOLLICLE STIMULATING HORMONE DIRECT RIA 07/23/1981
K803279 IMMUNO NUCLEAR CORP. FOLLICE STIMULATING HORMONE-RADIOIMM. KT 01/16/1981
K896864 IN VITRO DIAGNOSTICS, INC. FOLLICLE STIMULATING HORMONE-EIA-XT 01/11/1990
K052662 IND DIAGNOSTIC INC. ONE STEP FSH MENOPAUSAL TEST 11/30/2005
K813086 INTL. IMMUNOASSAY LABORATORIES, INC. ANDRIA-FSH RIA TEST KIT 12/17/1981
K952285 JOHNSON & JOHNSON CLINICAL DIAGNOSTICS, INC. AMERLITE FSH ASSAY 07/03/1995
K964720 JOHNSON & JOHNSON CLINICAL DIAGNOSTICS, INC. VITROS IMMUNODIAGNOSTICS PRODUCTS FSH REAGENT PACK (GEM. 1005) FSH CALIBRATORS (GEM.C005) 02/04/1997
K854837 LEECO DIAGNOSTICS, INC. LEE-BEAD BETA FSH (EIA) 01/13/1986
K810663 LEECO DIAGNOSTICS, INC. LEECO FSH-QUANT DIAGNOSTIC KIT 03/27/1981
K862043 LKB INSTRUMENTS, INC. DELFIA (TM) HFSH KIT 06/24/1986
K905814 LONDON DIAGNOSTICS, INC. LUMATAG(R) FSH CHEMILUMINESCENCE IMMUNOMETRI ASSAY 02/04/1991
K915208 MEDIX BIOTECH, INC. FSH ENZYME IMMUNASSAY TEST KIT NO:KIF4057 12/18/1991
K881596 MEDIX BIOTECH, INC. FSH ENZYME IMMUNOASSAY TEST KIT NO. MB-1057 05/27/1988
K896640 MEDIX BIOTECH, INC. MODIFIED FSH ENZYME IMMUNOASSAY TEST KIT 01/02/1990
K901345 MEDIX BIOTECH, INC. MODIFIED FSH ENZYME IMMUNOASSAY TEST KIT NO.MB1050 05/10/1990
K820740 MICROANALYTIC RESEARCH, INC. MR1 FOLLITROPIN RIA KIT 04/06/1982
K872309 MICROMEDIC SYSTEMS MICROMEDIC COMBOSTAT LH/FSH KIT 07/31/1987
K972720 MONOBIND FOLLICLE STIMULATING HORMONE (FSH) MICROPLATE ELISA (425-300) 09/02/1997
K820048 MONOBIND FSH RADIOIMMUNOASSAY TEST SYSTEM 02/04/1982
K834038 NEW ENGLAND NUCLEAR RIANEN FOLLICLE STIMULATING HORMONE 01/30/1984
K881123 NICHOLS INSTITUTE DIAGNOSTICS ALLEGRO(TM) FOLLICLE STIMULATING HORMONE IMMUNO. 04/28/1988
K863678 NICHOLS INSTITUTE DIAGNOSTICS FOLLICLE STIMULATING HORMONE IMMUNOASSAY SYSTEM 10/16/1986
K771756 NICHOLS INSTITUTE DIAGNOSTICS FOLLICLE-STIMULATING HORMONE 10/18/1977
K840230 PACIFIC BIOTECH, INC. FSH QUIK RIA KIT 03/23/1984
K912804 PANTEX, DIV. BIO-ANALYSIS, INC. FSH IRMA IMMUNOMAG 08/12/1991
K911409 PB DIAGNOSTIC SYSTEMS, INC. OPUS FSH 04/16/1991
K810852 PCL-RIA, INC. FOLLICLE STIMULATING HORMONE ANTISERUM 04/08/1981
K820358 PCL-RIA, INC. FOLLICLE STIMULATING HORMONE KIT 03/26/1982
K043599 PHAMATECH INC. MOMENTS MENOPAUSE CHECK, MODEL 9113 02/25/2005
K040575 PHAMATECH INC. PHARMATECH MENOPAUSE CHECK, MODELS 9111 AND 9112 05/20/2004
K800107 RADIOIMMUNOASSAY, INC. FOLLICLE STIMULATING HORMONE " " 02/13/1980
K930304 ROCHE DIAGNOSTIC SYSTEMS, INC. COBAS CORE FSH EIA 09/21/1993
K943437 SEALITE SCIENCES, INC. AQUALITE FSH 12/28/1994
K970085 SEALITE SCIENCES, INC. SEALITE SCIENCES AQUALITE FSH 02/14/1997
K862813 SERONO DIAGNOSTICS, INC. FSH MAIACLONE IMMUNORADIOMETRIC ASSAY KIT 09/16/1986
K872627 SERONO DIAGNOSTICS, INC. FSH SEROZYME IMMUNOENZYMETRIC ASSAY KIT/MAG SEP PH 07/21/1987
K892706 SERONO-BAKER DIAGNOSTICS, INC. SR1 (FSH) IMMUNOENZYMETRIC ASSAY 06/09/1989
K833852 SYNCOR INTL. CORP. FSH RIA 01/13/1984
K842444 SYNCOR INTL. CORP. FSH RIA 08/17/1984
K863928 TERUMO MEDICAL CORP. TERUMO SENSIBEAD EIA FSH KIT 12/04/1986
K792233 UNION CARBIDE CORP. CENTRIA FSH RIA 01/21/1980
K864080 UNITED BIOTECH, INC. UBI MAGIWEL(TM) FSH QUANTITATIVE 11/13/1986
K883279 VITEK SYSTEMS, INC. PHASE II FSH KIT 09/09/1988


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