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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 K980573
Device Name SENSOREX BLOOD GLUCOSE MONITORING SYSTEM
Applicant
Chronimed, Inc.
6214 Bury Dr.
Eden Prairie,  MN  55346
Applicant Contact JEFFREY P HEATON
Correspondent
Chronimed, Inc.
6214 Bury Dr.
Eden Prairie,  MN  55346
Correspondent Contact JEFFREY P HEATON
Regulation Number862.1345
Classification Product Code
CGA  
Date Received02/17/1998
Decision Date 07/30/1998
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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