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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Radioimmunoassay, Human Growth Hormone
510(k) Number K950510
Device Name OCTEIA IGF-1 KIT
Applicant
Immunodiagnostic Systems , Ltd.
Bolden Business Park
Boldon
Tyne And Wear,  GB NE35 9PD
Applicant Contact ANITA GROUNDWATER
Correspondent
Immunodiagnostic Systems , Ltd.
Bolden Business Park
Boldon
Tyne And Wear,  GB NE35 9PD
Correspondent Contact ANITA GROUNDWATER
Regulation Number862.1370
Classification Product Code
CFL  
Date Received02/06/1995
Decision Date 04/05/1995
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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