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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Glucose Oxidase, Glucose
510(k) Number K101947
Device Name IVD-GE02
Applicant
Sphere Medical , Ltd.
Harston Mill, Harston
Cambridge,  GB CM22 7GG
Applicant Contact MARY HUTCHENS
Correspondent
Sphere Medical , Ltd.
Harston Mill, Harston
Cambridge,  GB CM22 7GG
Correspondent Contact MARY HUTCHENS
Regulation Number862.1345
Classification Product Code
CGA  
Subsequent Product Codes
CEM   CHL   JIX  
Date Received07/12/2010
Decision Date 03/16/2011
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
Summary Summary
FDA Review Decision Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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