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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 K002621
Device Name GLUCOSURE BLOOD GLUCOSE MONITORING SYSTEM
Applicant
APEX BIOTECHNOLOGY CORP.
3600 HOLLY LN. N.
SUITE 90
PLYMOUTH,  MN  55447
Applicant Contact STEVEN CREES
Correspondent
APEX BIOTECHNOLOGY CORP.
3600 HOLLY LN. N.
SUITE 90
PLYMOUTH,  MN  55447
Correspondent Contact STEVEN CREES
Regulation Number862.1345
Classification Product Code
CGA  
Subsequent Product Code
NBW  
Date Received08/23/2000
Decision Date 01/22/2001
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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