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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 K022182
Device Name MEDISENSE PRECISION EASYBLOOD GLUCOSE MONITORING SYSTEM, MEDISENSE OPTIUM EASYBLOOD GLUCOSE MONITORING SYSTEM
Original Applicant
ABBOTT LABORATORIES
4-a crosby dr.
bedford,  MA  01730 1402
Original Contact janet connolly
Regulation Number862.1345
Classification Product Code
NBW  
Date Received07/03/2002
Decision Date 09/09/2002
Decision substantially equivalent (SE)
Classification Advisory Committee Clinical Chemistry
Review Advisory Committee Clinical Chemistry
summary summary
Type Traditional
Reviewed by Third Party No
Expedited Review No
Combination Product No
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