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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 K992684
Device Name FREESTYLE BLOOD GLUCOSE MONITORING SYSTEM
Applicant
ABBOTT DIABETES CARE INC.
1360 SOUTH LOOP DR.
ALAMEDA,  CA  94502 -7000
Applicant Contact EVE A CONNER
Correspondent
ABBOTT DIABETES CARE INC.
1360 SOUTH LOOP DR.
ALAMEDA,  CA  94502 -7000
Correspondent Contact EVE A CONNER
Regulation Number862.1345
Classification Product Code
LFR  
Date Received08/10/1999
Decision Date 01/14/2000
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
Recalls CDRH Recalls
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