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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 K880585
Device Name DEXPAD, BLOOD GLUCOSE STRIP
Applicant
Mach Diag. C/O Wichita State University
Wichita,  KS  67208
Applicant Contact JAMES A JACKSON
Correspondent
Mach Diag. C/O Wichita State University
Wichita,  KS  67208
Correspondent Contact JAMES A JACKSON
Regulation Number862.1345
Classification Product Code
CGA  
Date Received02/10/1988
Decision Date 04/18/1988
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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