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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, Test, Blood Glucose, Over The Counter
510(k) Number K023256
Device Name PRECISION XTRA/MEDISENSE OPTIUM/PRECISION EASY/MEDISENSE OPTIUM EASY BLOOD GLUCOSE TEST STRIP WITH TRUE MEASURE TECHNOLO
Applicant
Abbott Laboratories
4-A Crosby Dr.
Bedford,  MA  01730 -1402
Applicant Contact JANET CONNOLLY
Correspondent
Abbott Laboratories
4-A Crosby Dr.
Bedford,  MA  01730 -1402
Correspondent Contact JANET CONNOLLY
Regulation Number862.1345
Classification Product Code
NBW  
Subsequent Product Code
LFR  
Date Received09/30/2002
Decision Date 04/23/2003
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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