Radioimmunoassay, Follicle-Stimulating Hormone

FDA product code CGJ · 88 cleared devices

Class 1 Clinical Chemistry

Regulation: 21 CFR 862.1300
Review panel: CH
Implant: No
Life sustaining: No
Third party review: No
GMP exempt: No
Clearance span: 1976-11-01 – 2005-11-30

CGJ 2005-11-30

ONE STEP FSH MENOPAUSAL TEST

Applicant Ind Diagnostic, Inc.

K number K052662

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CGJ 2005-02-25

MOMENTS MENOPAUSE CHECK, MODEL 9113

Applicant Phamatech, Inc.

K number K043599

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CGJ 2004-06-17

FSH MENOPAUSE PREDICTOR TEST

Applicant ACON Laboratories, Inc.

K number K041165

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CGJ 2004-05-20

PHARMATECH MENOPAUSE CHECK, MODELS 9111 AND 9112

Applicant Phamatech, Inc.

K number K040575

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CGJ 2003-07-30

EARLYDETECT MENOPAUSE TEST FOR FSH

Applicant Early Detect, Inc.

K number K030058

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CGJ 2001-01-12

GENUA MENOPAUSE MONITOR TEST KIT

Applicant Genua 1944, Inc.

K number K002450

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CGJ 1997-09-02

FOLLICLE STIMULATING HORMONE (FSH) MICROPLATE ELISA (425-300)

Applicant Monobind

K number K972720

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CGJ 1997-02-14

SEALITE SCIENCES AQUALITE FSH

Applicant Sealite Sciences, Inc.

K number K970085

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CGJ 1997-02-04

VITROS IMMUNODIAGNOSTICS PRODUCTS FSH REAGENT PACK (GEM. 1005) FSH CALIBRATORS (GEM.C005)

Applicant Johnson & Johnson Clinical Diagnostics, Inc.

K number K964720

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CGJ 1996-12-16

ELECSYS FSH ASSAY

Applicant Boehringer Mannheim Corp.

K number K964693

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CGJ 1996-09-09

DSL ACTIVE FSH IRMA

Applicant Diagnostic Systems Laboratories, Inc.

K number K962118

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CGJ 1995-07-03

AMERLITE FSH ASSAY

Applicant Johnson & Johnson Clinical Diagnostics, Inc.

K number K952285

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CGJ 1994-12-28

AQUALITE FSH

Applicant Sealite Sciences, Inc.

K number K943437

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CGJ 1994-07-20

DUPONT ACA PLUS IMMUNOASSAY SYSTEM FOLLICLE STIMULATING HORMONE

Applicant Dupont Medical Products

K number K941221

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CGJ 1994-06-21

AXSYM FOLLICLE STIMULATING HORMONE (FSH)

Applicant Abbott Laboratories

K number K935612

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CGJ 1994-03-03

ACCESS HUMAN FOLLICLE STIMULATING HORMONE ASSAY

Applicant Bio-Rad Laboratories, Inc.

K number K940005

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CGJ 1993-09-21

COBAS CORE FSH EIA

Applicant Roche Diagnostic Systems, Inc.

K number K930304

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CGJ 1992-10-05

ICN BIOMEDICALS IMMUCHEM(TM) FSH-MW ELISA KIT

Applicant Icn Biomedicals, Inc.

K number K922376

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CGJ 1992-06-16

VITEK IMMUNODIAGNOSTIC ASSAY SYSTEM

Applicant Biomerieux Vitek, Inc.

K number K921746

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CGJ 1992-06-09

IMMULITE(R) FSH

Applicant Cirrus Diagnostics, Inc.

K number K921704

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CGJ 1992-03-26

ELISA TUBE FSH TEST KIT ENZYME LINKED IMMUN. ASSAY

Applicant Bio Clinic Co.

K number K920917

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CGJ 1991-12-18

FSH ENZYME IMMUNASSAY TEST KIT NO:KIF4057

Applicant Medix Biotech, Inc.

K number K915208

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CGJ 1991-08-12

FSH IRMA IMMUNOMAG

Applicant Pantex, Div. Bio-Analysis, Inc.

K number K912804

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CGJ 1991-04-16

OPUS FSH

Applicant Pb Diagnostic Systems, Inc.

K number K911409

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CGJ 1991-02-04

LUMATAG(R) FSH CHEMILUMINESCENCE IMMUNOMETRI ASSAY

Applicant London Diagnostics, Inc.

K number K905814

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CGJ 1990-12-27

AFFINITY FSH TEST SYSTEM

Applicant Bd Becton Dickinson Vacutainer Systems Preanalytic

K number K905592

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CGJ 1990-11-20

CIBA CORNING ACS FSH IMMUNOASSAY

Applicant Ciba Corning Diagnostics Corp.

K number K904649

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CGJ 1990-10-26

BIOCLONES ELEGANCE FSH ELISA KIT

Applicant Bioclone Australia Pty , Ltd.

K number K904405

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CGJ 1990-05-10

MODIFIED FSH ENZYME IMMUNOASSAY TEST KIT NO.MB1050

Applicant Medix Biotech, Inc.

K number K901345

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CGJ 1990-03-15

ENZYMUN TEST(R) FSH

Applicant Boehringer Mannheim Corp.

K number K900763

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CGJ 1990-01-11

FOLLICLE STIMULATING HORMONE-EIA-XT

Applicant In Vitro Diagnostics, Inc.

K number K896864

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CGJ 1990-01-02

MODIFIED FSH ENZYME IMMUNOASSAY TEST KIT

Applicant Medix Biotech, Inc.

K number K896640

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CGJ 1989-10-31

MILENIA(TM) FSH (MKFS1,5)

Applicant Diagnostic Products Corp.

K number K895005

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CGJ 1989-10-23

FOLLICLE STIMULATING HORMONE MAB SOLID PHASE COM.

Applicant Bd Becton Dickinson Vacutainer Systems Preanalytic

K number K895108

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CGJ 1989-09-13

TANDEM-E FSH IMMUNOENZYMETRIC ASSAY KIT

Applicant Hybritech, Inc.

K number K894761

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CGJ 1989-08-17

COAT-A-COUNT (TM) FSH IRMA

Applicant Diagnostic Products Corp.

K number K893976

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CGJ 1989-06-09

SR1 (FSH) IMMUNOENZYMETRIC ASSAY

Applicant Serono-Baker Diagnostics, Inc.

K number K892706

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CGJ 1989-02-10

IMX FOLLICLE STIMULATING HORMONE (FSH)

Applicant Abbott Laboratories

K number K890135

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CGJ 1989-01-17

FIAGEN HFSH TIME-RESOLVED FLUOROIMMUNOASSAY KIT

Applicant Cyberfluor, Inc.

K number K884708

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CGJ 1988-12-06

CIBA CORNING MAGIC LITE FSH IMMUNOASSAY

Applicant Ciba Corning Diagnostics Corp.

K number K884687

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CGJ 1988-11-30

IRMA-COUNT(TM) FSH W/MONOCLONAL ANTIBODIES

Applicant Diagnostic Products Corp.

K number K883745

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CGJ 1988-10-06

BINAX FSH IRMA TEST KIT, IMMUNORADIOMETRIC ASSAY

Applicant Binax, Inc.

K number K883305

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CGJ 1988-09-09

PHASE II FSH KIT

Applicant Vitek Systems, Inc.

K number K883279

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CGJ 1988-07-21

AMERLITE FSH ASSAY, LAN.0077/2077 240 AND 144 TEST

Applicant Amersham Corp.

K number K881142

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CGJ 1988-05-27

FSH ENZYME IMMUNOASSAY TEST KIT NO. MB-1057

Applicant Medix Biotech, Inc.

K number K881596

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CGJ 1988-04-28

ALLEGRO(TM) FOLLICLE STIMULATING HORMONE IMMUNO.

Applicant Nichols Institute Diagnostics

K number K881123

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CGJ 1987-10-20

STRATUS(R) HFSH FLUOROMETRIC ENZYME IMMUNOASSAY

Applicant American Dade

K number K873051

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CGJ 1987-07-31

MICROMEDIC COMBOSTAT LH/FSH KIT

Applicant Micromedic Systems

K number K872309

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CGJ 1987-07-21

FSH SEROZYME IMMUNOENZYMETRIC ASSAY KIT/MAG SEP PH

Applicant Serono Diagnostics, Inc.

K number K872627

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CGJ 1987-05-20

FOLLICLE STIMULATING HORMONE (HFSH)

Applicant Immuchem Corp.

K number K871317

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CGJ 1987-03-10

TANDEM(R)-M FSH IMMUNOENZYMETRIC ASSAY

Applicant Hybritech, Inc.

K number K870520

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CGJ 1986-12-04

TERUMO SENSIBEAD EIA FSH KIT

Applicant Terumo Medical Corp.

K number K863928

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CGJ 1986-11-13

UBI MAGIWEL(TM) FSH QUANTITATIVE

Applicant United Biotech, Inc.

K number K864080

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CGJ 1986-10-16

FOLLICLE STIMULATING HORMONE IMMUNOASSAY SYSTEM

Applicant Nichols Institute Diagnostics

K number K863678

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CGJ 1986-09-16

FSH MAIACLONE IMMUNORADIOMETRIC ASSAY KIT

Applicant Serono Diagnostics, Inc.

K number K862813

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CGJ 1986-08-19

SUCROSEP FOLLICLE STIMULATING HORMONE (FSH) IRMA

Applicant Boots-Celltech Diagnostics, Inc.

K number K862439

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CGJ 1986-06-24

DELFIA (TM) HFSH KIT

Applicant Lkb Instruments, Inc.

K number K862043

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CGJ 1986-01-13

LEE-BEAD BETA FSH (EIA)

Applicant Leeco Diagnostics, Inc.

K number K854837

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CGJ 1985-12-13

PARAAMAX CHLORIDE DETERMINATION BY ISE

Applicant American Dade

K number K854651

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CGJ 1985-05-07

AMERLEX-M FOLLICLE STIMULATING HORMONE(FSH)RADIOIM

Applicant Amersham Corp.

K number K851361

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CGJ 1985-01-18

COTROPIN STIMULATANEOUS 57 CO-LH 125I I-FSH

Applicant Clinetics Corp.

K number K844066

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CGJ 1984-10-30

IRMA IMMUNORADIOMETRIC ASSAY-FSH 125I

Applicant Euro-Diagnostics BV

K number K843930

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CGJ 1984-08-17

FSH RIA

Applicant Syncor Intl. Corp.

K number K842444

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CGJ 1984-03-23

FSH QUIK RIA KIT

Applicant Pacific Biotech, Inc.

K number K840230

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CGJ 1984-01-30

RIANEN FOLLICLE STIMULATING HORMONE

Applicant New England Nuclear

K number K834038

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CGJ 1984-01-13

FSH RIA

Applicant Syncor Intl. Corp.

K number K833852

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CGJ 1983-07-18

QUANTIMUNE HFSH RIA HUMAN FOLLICLE-

Applicant Bio-Rad

K number K831742

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CGJ 1982-12-22

125-I FSH RADIOIMMUNOASSAY KIT

Applicant Clinetics Corp.

K number K823379

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CGJ 1982-08-16

IMMO PHASE FSH RADIOIMMUNOASSAY

Applicant Corning Medical & Scientific

K number K822227

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CGJ 1982-06-24

GAMMADAB [125] FSH RADIOIMMUNAY KIT

Applicant Clinical Assays, Inc.

K number K821611

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CGJ 1982-04-15

AMERLEX ESH KIT

Applicant Amersham Corp.

K number K820754

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CGJ 1982-04-06

MR1 FOLLITROPIN RIA KIT

Applicant Microanalytic Research, Inc.

K number K820740

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CGJ 1982-03-26

FOLLICLE STIMULATING HORMONE KIT

Applicant Pcl-Ria, Inc.

K number K820358

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CGJ 1982-02-04

FSH RADIOIMMUNOASSAY TEST SYSTEM

Applicant Monobind

K number K820048

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CGJ 1981-12-17

ANDRIA-FSH RIA TEST KIT

Applicant Intl. Immunoassay Laboratories, Inc.

K number K813086

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CGJ 1981-08-03