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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 K011479
Device Name ONE TOUCH FASTTAKE COMPACT BLOOD GLUCOSE MONITORING SYSTEM, ONE TOUCH ULTRA BLOOD GLUCOSE MONITORING SYSTEM
Applicant
Inverness Medical Innovations, Inc.
51 Sawyer Rd., Suite 200
Waltham,  MA  02453 -3448
Applicant Contact CAROL A ADILETTO
Correspondent
Inverness Medical Innovations, Inc.
51 Sawyer Rd., Suite 200
Waltham,  MA  02453 -3448
Correspondent Contact CAROL A ADILETTO
Regulation Number862.1345
Classification Product Code
CGA  
Subsequent Product Code
NBW  
Date Received05/14/2001
Decision Date 11/30/2001
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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