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 |