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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 K931196
Device Name APEC GLUCOSE ANALYZER
Applicant
Apec, Inc.
Cherry Hill Commerce Center
42a Cherry Hill Dr.
Danvers,  MA  01923
Applicant Contact DONALD SCHWARTZ
Correspondent
Apec, Inc.
Cherry Hill Commerce Center
42a Cherry Hill Dr.
Danvers,  MA  01923
Correspondent Contact DONALD SCHWARTZ
Regulation Number862.1345
Classification Product Code
CGA  
Date Received03/09/1993
Decision Date 12/07/1993
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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