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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 K931188
Device Name CHECKMATE PLUS BLOOD GLUCOSE METER, TEST STRIP,ETC
Applicant
Cascade Medical, Inc.
10180 Viking Dr.
Eden Prairie,  MN  55344
Applicant Contact ROBERT E MEYER
Correspondent
Cascade Medical, Inc.
10180 Viking Dr.
Eden Prairie,  MN  55344
Correspondent Contact ROBERT E MEYER
Regulation Number862.1345
Classification Product Code
CGA  
Date Received03/09/1993
Decision Date 05/26/1993
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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