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

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

FDA 510(k) Number	Applicant	Device Name	Decision Date
K041165	ACON LABORATORIES, INC.	FSH MENOPAUSE PREDICTOR TEST	06/17/2004
K964693	BOEHRINGER MANNHEIM CORP.	ELECSYS FSH ASSAY	12/16/1996
K962118	DIAGNOSTIC SYSTEMS LABORATORIES, INC.	DSL ACTIVE FSH IRMA	09/09/1996
K030058	EARLY DETECT, INC.	EARLYDETECT MENOPAUSE TEST FOR FSH	07/30/2003
K002450	GENUA 1944, INC.	GENUA MENOPAUSE MONITOR TEST KIT	01/12/2001
K052662	IND DIAGNOSTIC INC.	ONE STEP FSH MENOPAUSAL TEST	11/30/2005
K964720	JOHNSON & JOHNSON CLINICAL DIAGNOSTICS, INC.	VITROS IMMUNODIAGNOSTICS PRODUCTS FSH REAGENT PACK (GEM. 1005) FSH CALIBRATORS (GEM.C005)	02/04/1997
K972720	MONOBIND	FOLLICLE STIMULATING HORMONE (FSH) MICROPLATE ELISA (425-300)	09/02/1997
K043599	PHAMATECH INC.	MOMENTS MENOPAUSE CHECK, MODEL 9113	02/25/2005
K040575	PHAMATECH INC.	PHARMATECH MENOPAUSE CHECK, MODELS 9111 AND 9112	05/20/2004
K970085	SEALITE SCIENCES, INC.	SEALITE SCIENCES AQUALITE FSH	02/14/1997