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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name glucose dehydrogenase, glucose
510(k) Number K022941
Device Name MEDISENSE PRECISION PCX POINT OF CARE MANAGEMENT SYSTEM FOR BLOOD GLUCOSE TESTING
Applicant
ABBOTT LABORATORIES
4-A CROSBY DR.
BEDFORD,  MA  01730 -1402
Applicant Contact JOSEPH MAGLIOZZI
Correspondent
ABBOTT LABORATORIES
4-A CROSBY DR.
BEDFORD,  MA  01730 -1402
Correspondent Contact JOSEPH MAGLIOZZI
Regulation Number862.1345
Classification Product Code
LFR  
Subsequent Product Code
NBW  
Date Received09/03/2002
Decision Date 10/28/2002
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
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