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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