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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 K854260
Device Name CHEMPRO 1000
Applicant
Sen Tech Medical Corp.
3771 Lexington Ave.
Arden Hills,  MN  55112
Applicant Contact WALTER SEMBROWICH
Correspondent
Sen Tech Medical Corp.
3771 Lexington Ave.
Arden Hills,  MN  55112
Correspondent Contact WALTER SEMBROWICH
Regulation Number862.1345
Classification Product Code
CGA  
Date Received10/23/1985
Decision Date 11/19/1985
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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