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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 K010039
Device Name QUICKTEK BLOOD GLUCOSE SYSTEM, QUICKTEK BLOOD GLUCOSE METER, QUICKTEK BLOOD GLUCOSE STRIPS, QUICKTEK CONTROL SOLUTION
Applicant
Chronimed, Inc.
6214 Bury Dr.
Eden Prairie,  MN  55346
Applicant Contact BRUCE A MACFARLANE
Correspondent
Chronimed, Inc.
6214 Bury Dr.
Eden Prairie,  MN  55346
Correspondent Contact BRUCE A MACFARLANE
Regulation Number862.1345
Classification Product Code
NBW  
Date Received01/05/2001
Decision Date 08/10/2001
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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