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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 K943503
Device Name CHEMCARD GLUCOSE TEST
Applicant
Chem-Elec, Inc.
P.O. Box 372
North Webster,  IN  46555
Applicant Contact WILLIAM E WOENKER
Correspondent
Chem-Elec, Inc.
P.O. Box 372
North Webster,  IN  46555
Correspondent Contact WILLIAM E WOENKER
Regulation Number862.1345
Classification Product Code
CGA  
Date Received07/20/1994
Decision Date 07/23/1996
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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