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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 K091975
Device Name INTEGRATED LABORATORY AUTOMATION SOLUTION
Applicant
Integrated Laboratory Automation Solutions, Inc.
55 Northern Blvd., Suite 200
Great Neck,  NY  11021
Applicant Contact MARIA F GRIFFIN
Correspondent
Integrated Laboratory Automation Solutions, Inc.
55 Northern Blvd., Suite 200
Great Neck,  NY  11021
Correspondent Contact MARIA F GRIFFIN
Regulation Number862.1345
Classification Product Code
CGA  
Subsequent Product Code
JJE  
Date Received07/01/2009
Decision Date 03/10/2010
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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