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CGJ — Radioimmunoassay, Follicle-Stimulating Hormone Class I

FDA Device Classification

Classification Details

Product Code
CGJ
Device Class
Class I
Regulation Number
862.1300
Submission Type
Review Panel
CH
Medical Specialty
Clinical Chemistry
Implant
No

Recent 510(k) Clearances

K-NumberApplicantDevice NameDate
K052662ind diagnosticONE STEP FSH MENOPAUSAL TESTNovember 30, 2005
K043599phamatechMOMENTS MENOPAUSE CHECK, MODEL 9113February 25, 2005
K041165acon laboratoriesFSH MENOPAUSE PREDICTOR TESTJune 17, 2004
K040575phamatechPHARMATECH MENOPAUSE CHECK, MODELS 9111 AND 9112May 20, 2004
K030058early detectEARLYDETECT MENOPAUSE TEST FOR FSHJuly 30, 2003
K002450genua 1944GENUA MENOPAUSE MONITOR TEST KITJanuary 12, 2001
K972720monobindFOLLICLE STIMULATING HORMONE (FSH) MICROPLATE ELISA (425-300)September 2, 1997
K970085sealite sciencesSEALITE SCIENCES AQUALITE FSHFebruary 14, 1997
K964720johnson and johnson clinical diagnosticsVITROS IMMUNODIAGNOSTICS PRODUCTS FSH REAGENT PACK (GEM. 1005) FSH CALIBRATORS (February 4, 1997
K964693boehringer mannheimELECSYS FSH ASSAYDecember 16, 1996
K962118diagnostic systems laboratoriesDSL ACTIVE FSH IRMASeptember 9, 1996
K952285johnson and johnson clinical diagnosticsAMERLITE FSH ASSAYJuly 3, 1995
K943437sealite sciencesAQUALITE FSHDecember 28, 1994
K941221dupont medical productsDUPONT ACA PLUS IMMUNOASSAY SYSTEM FOLLICLE STIMULATING HORMONEJuly 20, 1994
K935612abbott laboratoriesAXSYM FOLLICLE STIMULATING HORMONE (FSH)June 21, 1994
K940005bio-rad laboratoriesACCESS HUMAN FOLLICLE STIMULATING HORMONE ASSAYMarch 3, 1994
K930304roche diagnostic systemsCOBAS CORE FSH EIASeptember 21, 1993
K922376icn biomedicalsICN BIOMEDICALS IMMUCHEM(TM) FSH-MW ELISA KITOctober 5, 1992
K921746biomerieux vitekVITEK IMMUNODIAGNOSTIC ASSAY SYSTEMJune 16, 1992
K921704cirrus diagnosticsIMMULITE(R) FSHJune 9, 1992