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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 K896144
Device Name AUTOSCAN, AUTOSTRIP AND AUTOCONTROL
Applicant
Cascade Medical, Inc.
10180 Viking Dr.
Eden Prairie,  MN  55344
Applicant Contact MEYER, PE
Correspondent
Cascade Medical, Inc.
10180 Viking Dr.
Eden Prairie,  MN  55344
Correspondent Contact MEYER, PE
Regulation Number862.1345
Classification Product Code
CGA  
Date Received10/23/1989
Decision Date 12/19/1989
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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