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510(k) K823379

Device
125-I FSH RADIOIMMUNOASSAY KIT
Applicant
CLINETICS CORP.
510(k) number
K823379
Product code
CGJ  
Decision
Substantially Equivalent (SESE)
Decision date
1982-12-22
Date received
1982-11-12
Regulation
862.1300
Classification name
Radioimmunoassay, Follicle-stimulating Hormone
Medical specialty
Clinical Chemistry
Review panel
Clinical Chemistry
Device class
1
Clearance type
Traditional
Third party reviewed
No

Applicant Contact#

Address
803 N. Front St. Suite 3 Mchenry IL US 60050 60050

FDA Registration Numbers#

Source Documents#

510(k) summary PDF not indicated by FDA

Other 510(k) Records For Product Code CGJ  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K052662ONE STEP FSH MENOPAUSAL TESTInd Diagnostic, Inc.2005-11-30
K043599MOMENTS MENOPAUSE CHECK, MODEL 9113Phamatech, Inc.2005-02-25
K041165FSH MENOPAUSE PREDICTOR TESTACON Laboratories, Inc.2004-06-17
K040575PHARMATECH MENOPAUSE CHECK, MODELS 9111 AND 9112Phamatech, Inc.2004-05-20
K030058EARLYDETECT MENOPAUSE TEST FOR FSHEarly Detect, Inc.2003-07-30
K002450GENUA MENOPAUSE MONITOR TEST KITGenua 1944, Inc.2001-01-12
K972720FOLLICLE STIMULATING HORMONE (FSH) MICROPLATE ELISA (425-300)Monobind1997-09-02
K970085SEALITE SCIENCES AQUALITE FSHSealite Sciences, Inc.1997-02-14
K964720VITROS IMMUNODIAGNOSTICS PRODUCTS FSH REAGENT PACK (GEM. 1005) FSH CALIBRATORS (GEM.C005)Johnson & Johnson Clinical Diagnostics, Inc.1997-02-04
K964693ELECSYS FSH ASSAYBoehringer Mannheim Corp.1996-12-16
K962118DSL ACTIVE FSH IRMADiagnostic Systems Laboratories, Inc.1996-09-09
K952285AMERLITE FSH ASSAYJohnson & Johnson Clinical Diagnostics, Inc.1995-07-03
K943437AQUALITE FSHSealite Sciences, Inc.1994-12-28
K941221DUPONT ACA PLUS IMMUNOASSAY SYSTEM FOLLICLE STIMULATING HORMONEDupont Medical Products1994-07-20
K935612AXSYM FOLLICLE STIMULATING HORMONE (FSH)Abbott Laboratories1994-06-21

Legacy Summary#

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FDA Review#

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