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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 K852960
Device Name DIRECT
Applicant
University of Wisconsin
600 Highland Ave.
Madison,  WI  53792
Applicant Contact STUART J UPDIKE
Correspondent
University of Wisconsin
600 Highland Ave.
Madison,  WI  53792
Correspondent Contact STUART J UPDIKE
Regulation Number862.1345
Classification Product Code
CGA  
Date Received07/12/1985
Decision Date 06/16/1986
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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