Product Code: CGJ FDA class 1 21 CFR 862.1300

Radioimmunoassay, Follicle-Stimulating Hormone

Clinical Chemistry

The Radioimmunoassay, Follicle-Stimulating Hormone test system (product code CGJ) is an in-vitro diagnostic device used in clinical chemistry to quantify follicle-stimulating hormone (FSH) in serum or urine using a radioimmunoassay method, supporting the evaluation of reproductive and endocrine disorders. It is classified as FDA Class 1, the lowest risk tier, subject to general controls only and not requiring premarket notification. It falls under regulation 21 CFR 862.1300 in the Clinical Chemistry medical specialty.

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Basic Information

Product Code: CGJ
Device Class: FDA class 1
Regulation Number: 862.1300
Medical Specialty: Clinical Chemistry
Review Panel: CH
Submission Type: 4

Device Characteristics

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GMP Exempt

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Implant

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Life Sustain/Support

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Third Party

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Summary Malfunction Reporting

510(k) Clearance History

Related 510(k) Clearances

This FDA classification is associated with 88 510(k) clearances via K numbers.

K Number	Device Name	Decision Date	Decision	Applicant
K052662	ONE STEP FSH MENOPAUSAL TEST	Nov 30, 2005	Substantially Equivalent	Ind Diagnostic, Inc.
K043599	MOMENTS MENOPAUSE CHECK, MODEL 9113	Feb 25, 2005	Substantially Equivalent	Phamatech, Inc.
K041165	FSH MENOPAUSE PREDICTOR TEST	Jun 17, 2004	Substantially Equivalent	ACON Laboratories, Inc.
K040575	PHARMATECH MENOPAUSE CHECK, MODELS 9111 AND 9112	May 20, 2004	Substantially Equivalent	Phamatech, Inc.
K030058	EARLYDETECT MENOPAUSE TEST FOR FSH	Jul 30, 2003	Substantially Equivalent	Early Detect, Inc.
K002450	GENUA MENOPAUSE MONITOR TEST KIT	Jan 12, 2001	Substantially Equivalent	Genua 1944, Inc.
K972720	FOLLICLE STIMULATING HORMONE (FSH) MICROPLATE ELISA (425-300)	Sep 02, 1997	Substantially Equivalent	Monobind
K970085	SEALITE SCIENCES AQUALITE FSH	Feb 14, 1997	Substantially Equivalent	Sealite Sciences, Inc.
K964720	VITROS IMMUNODIAGNOSTICS PRODUCTS FSH REAGENT PACK (GEM. 1005) FSH CALIBRATORS (GEM.C005)	Feb 04, 1997	Substantially Equivalent	Johnson & Johnson Clinical Diagnostics, Inc.
K964693	ELECSYS FSH ASSAY	Dec 16, 1996	Substantially Equivalent	Boehringer Mannheim Corp.
K962118	DSL ACTIVE FSH IRMA	Sep 09, 1996	Substantially Equivalent	Diagnostic Systems Laboratories, Inc.
K952285	AMERLITE FSH ASSAY	Jul 03, 1995	Substantially Equivalent	Johnson & Johnson Clinical Diagnostics, Inc.
K943437	AQUALITE FSH	Dec 28, 1994	Substantially Equivalent	Sealite Sciences, Inc.
K941221	DUPONT ACA PLUS IMMUNOASSAY SYSTEM FOLLICLE STIMULATING HORMONE	Jul 20, 1994	Substantially Equivalent	Dupont Medical Products
K935612	AXSYM FOLLICLE STIMULATING HORMONE (FSH)	Jun 21, 1994	Substantially Equivalent	Abbott Laboratories
K940005	ACCESS HUMAN FOLLICLE STIMULATING HORMONE ASSAY	Mar 03, 1994	Substantially Equivalent	Bio-Rad Laboratories, Inc.
K930304	COBAS CORE FSH EIA	Sep 21, 1993	Substantially Equivalent	Roche Diagnostic Systems, Inc.
K922376	ICN BIOMEDICALS IMMUCHEM(TM) FSH-MW ELISA KIT	Oct 05, 1992	Substantially Equivalent	Icn Biomedicals, Inc.
K921746	VITEK IMMUNODIAGNOSTIC ASSAY SYSTEM	Jun 16, 1992	Substantially Equivalent	Biomerieux Vitek, Inc.
K921704	IMMULITE(R) FSH	Jun 09, 1992	Substantially Equivalent	Cirrus Diagnostics, Inc.
K920917	ELISA TUBE FSH TEST KIT ENZYME LINKED IMMUN. ASSAY	Mar 26, 1992	Substantially Equivalent	Bio Clinic Co.
K915208	FSH ENZYME IMMUNASSAY TEST KIT NO:KIF4057	Dec 18, 1991	Substantially Equivalent	Medix Biotech, Inc.
K912804	FSH IRMA IMMUNOMAG	Aug 12, 1991	Substantially Equivalent	Pantex, Div. Bio-Analysis, Inc.
K911409	OPUS FSH	Apr 16, 1991	Substantially Equivalent	Pb Diagnostic Systems, Inc.
K905814	LUMATAG(R) FSH CHEMILUMINESCENCE IMMUNOMETRI ASSAY	Feb 04, 1991	Substantially Equivalent	London Diagnostics, Inc.
K905592	AFFINITY FSH TEST SYSTEM	Dec 27, 1990	Substantially Equivalent	Bd Becton Dickinson Vacutainer Systems Preanalytic
K904649	CIBA CORNING ACS FSH IMMUNOASSAY	Nov 20, 1990	Substantially Equivalent	Ciba Corning Diagnostics Corp.
K904405	BIOCLONES ELEGANCE FSH ELISA KIT	Oct 26, 1990	Substantially Equivalent	Bioclone Australia Pty , Ltd.
K901345	MODIFIED FSH ENZYME IMMUNOASSAY TEST KIT NO.MB1050	May 10, 1990	Substantially Equivalent	Medix Biotech, Inc.
K900763	ENZYMUN TEST(R) FSH	Mar 15, 1990	Substantially Equivalent	Boehringer Mannheim Corp.
K896864	FOLLICLE STIMULATING HORMONE-EIA-XT	Jan 11, 1990	Substantially Equivalent	In Vitro Diagnostics, Inc.
K896640	MODIFIED FSH ENZYME IMMUNOASSAY TEST KIT	Jan 02, 1990	Substantially Equivalent	Medix Biotech, Inc.
K895005	MILENIA(TM) FSH (MKFS1,5)	Oct 31, 1989	Substantially Equivalent	Diagnostic Products Corp.
K895108	FOLLICLE STIMULATING HORMONE MAB SOLID PHASE COM.	Oct 23, 1989	Substantially Equivalent	Bd Becton Dickinson Vacutainer Systems Preanalytic
K894761	TANDEM-E FSH IMMUNOENZYMETRIC ASSAY KIT	Sep 13, 1989	Substantially Equivalent	Hybritech, Inc.
K893976	COAT-A-COUNT (TM) FSH IRMA	Aug 17, 1989	Substantially Equivalent	Diagnostic Products Corp.
K892706	SR1 (FSH) IMMUNOENZYMETRIC ASSAY	Jun 09, 1989	Substantially Equivalent	Serono-Baker Diagnostics, Inc.
K890135	IMX FOLLICLE STIMULATING HORMONE (FSH)	Feb 10, 1989	Substantially Equivalent	Abbott Laboratories
K884708	FIAGEN HFSH TIME-RESOLVED FLUOROIMMUNOASSAY KIT	Jan 17, 1989	Substantially Equivalent	Cyberfluor, Inc.
K884687	CIBA CORNING MAGIC LITE FSH IMMUNOASSAY	Dec 06, 1988	Substantially Equivalent	Ciba Corning Diagnostics Corp.
K883745	IRMA-COUNT(TM) FSH W/MONOCLONAL ANTIBODIES	Nov 30, 1988	Substantially Equivalent	Diagnostic Products Corp.
K883305	BINAX FSH IRMA TEST KIT, IMMUNORADIOMETRIC ASSAY	Oct 06, 1988	Substantially Equivalent	Binax, Inc.
K883279	PHASE II FSH KIT	Sep 09, 1988	Substantially Equivalent	Vitek Systems, Inc.
K881142	AMERLITE FSH ASSAY, LAN.0077/2077 240 AND 144 TEST	Jul 21, 1988	Substantially Equivalent	Amersham Corp.
K881596	FSH ENZYME IMMUNOASSAY TEST KIT NO. MB-1057	May 27, 1988	Substantially Equivalent	Medix Biotech, Inc.
K881123	ALLEGRO(TM) FOLLICLE STIMULATING HORMONE IMMUNO.	Apr 28, 1988	Substantially Equivalent	Nichols Institute Diagnostics
K873051	STRATUS(R) HFSH FLUOROMETRIC ENZYME IMMUNOASSAY	Oct 20, 1987	Substantially Equivalent	American Dade
K872309	MICROMEDIC COMBOSTAT LH/FSH KIT	Jul 31, 1987	Substantially Equivalent	Micromedic Systems
K872627	FSH SEROZYME IMMUNOENZYMETRIC ASSAY KIT/MAG SEP PH	Jul 21, 1987	Substantially Equivalent	Serono Diagnostics, Inc.
K871317	FOLLICLE STIMULATING HORMONE (HFSH)	May 20, 1987	Substantially Equivalent	Immuchem Corp.
K870520	TANDEM(R)-M FSH IMMUNOENZYMETRIC ASSAY	Mar 10, 1987	Substantially Equivalent	Hybritech, Inc.
K863928	TERUMO SENSIBEAD EIA FSH KIT	Dec 04, 1986	Substantially Equivalent	Terumo Medical Corp.
K864080	UBI MAGIWEL(TM) FSH QUANTITATIVE	Nov 13, 1986	Substantially Equivalent	United Biotech, Inc.
K863678	FOLLICLE STIMULATING HORMONE IMMUNOASSAY SYSTEM	Oct 16, 1986	Substantially Equivalent	Nichols Institute Diagnostics
K862813	FSH MAIACLONE IMMUNORADIOMETRIC ASSAY KIT	Sep 16, 1986	Substantially Equivalent	Serono Diagnostics, Inc.
K862439	SUCROSEP FOLLICLE STIMULATING HORMONE (FSH) IRMA	Aug 19, 1986	Substantially Equivalent	Boots-Celltech Diagnostics, Inc.
K862043	DELFIA (TM) HFSH KIT	Jun 24, 1986	Substantially Equivalent	Lkb Instruments, Inc.
K854837	LEE-BEAD BETA FSH (EIA)	Jan 13, 1986	Substantially Equivalent	Leeco Diagnostics, Inc.
K854651	PARAAMAX CHLORIDE DETERMINATION BY ISE	Dec 13, 1985	Substantially Equivalent	American Dade
K851361	AMERLEX-M FOLLICLE STIMULATING HORMONE(FSH)RADIOIM	May 07, 1985	Substantially Equivalent	Amersham Corp.
K844066	COTROPIN STIMULATANEOUS 57 CO-LH 125I I-FSH	Jan 18, 1985	Substantially Equivalent	Clinetics Corp.
K843930	IRMA IMMUNORADIOMETRIC ASSAY-FSH 125I	Oct 30, 1984	Substantially Equivalent	Euro-Diagnostics BV
K842444	FSH RIA	Aug 17, 1984	Substantially Equivalent	Syncor Intl. Corp.
K840230	FSH QUIK RIA KIT	Mar 23, 1984	Substantially Equivalent	Pacific Biotech, Inc.
K834038	RIANEN FOLLICLE STIMULATING HORMONE	Jan 30, 1984	Substantially Equivalent	New England Nuclear
K833852	FSH RIA	Jan 13, 1984	Substantially Equivalent	Syncor Intl. Corp.
K831742	QUANTIMUNE HFSH RIA HUMAN FOLLICLE-	Jul 18, 1983	Substantially Equivalent	Bio-Rad
K823379	125-I FSH RADIOIMMUNOASSAY KIT	Dec 22, 1982	Substantially Equivalent	Clinetics Corp.
K822227	IMMO PHASE FSH RADIOIMMUNOASSAY	Aug 16, 1982	Substantially Equivalent	Corning Medical & Scientific
K821611	GAMMADAB [125] FSH RADIOIMMUNAY KIT	Jun 24, 1982	Substantially Equivalent	Clinical Assays, Inc.
K820754	AMERLEX ESH KIT	Apr 15, 1982	Substantially Equivalent	Amersham Corp.
K820740	MR1 FOLLITROPIN RIA KIT	Apr 06, 1982	Substantially Equivalent	Microanalytic Research, Inc.
K820358	FOLLICLE STIMULATING HORMONE KIT	Mar 26, 1982	Substantially Equivalent	Pcl-Ria, Inc.
K820048	FSH RADIOIMMUNOASSAY TEST SYSTEM	Feb 04, 1982	Substantially Equivalent	Monobind
K813086	ANDRIA-FSH RIA TEST KIT	Dec 17, 1981	Substantially Equivalent	Intl. Immunoassay Laboratories, Inc.
K811993	RADIOIMMUNOASSAY, FOLLICLE STIMULATING	Aug 03, 1981	Substantially Equivalent	Endocrine-Metabolic Center
K811905	FOLLICLE STIMULATING HORMONE DIRECT RIA	Jul 23, 1981	Substantially Equivalent	Immunalysis Corporation
K810852	FOLLICLE STIMULATING HORMONE ANTISERUM	Apr 08, 1981	Substantially Equivalent	Pcl-Ria, Inc.
K810663	LEECO FSH-QUANT DIAGNOSTIC KIT	Mar 27, 1981	Substantially Equivalent	Leeco Diagnostics, Inc.
K810381	HTSH RIABEAD DIAGNOSTIC KIT	Feb 26, 1981	Substantially Equivalent	Abbott Laboratories
K803279	FOLLICE STIMULATING HORMONE-RADIOIMM. KT	Jan 16, 1981	Substantially Equivalent	Immuno Nuclear Corp.
K800107	FOLLICLE STIMULATING HORMONE	Feb 13, 1980	Substantially Equivalent	Radioimmunoassay, Inc.
K792233	CENTRIA FSH RIA	Jan 21, 1980	Substantially Equivalent	Union Carbide Corp.
K792063	FOLLICLE STIMULATING HORMONE (FSH) KIT	Nov 20, 1979	Substantially Equivalent	Cis Radiopharmaceuticals, Inc.
K791836	QUANTIMUNE HFSH RIA	Oct 01, 1979	Substantially Equivalent	Bio-Rad
K780870	RIA SYSTEM FOR HUMAN F-S HORMONE	Jun 22, 1978	Substantially Equivalent	Calbiochem-Behring Corp.
K771756	FOLLICLE-STIMULATING HORMONE	Oct 18, 1977	Substantially Equivalent	Nichols Institute Diagnostics
K760373	RADIOASSAY KIT, IM.72 FSH	Nov 01, 1976	Substantially Equivalent	Amersham Corp.