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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 K791669
Device Name GLUCOSE OXIDASE REAGENT SET
Applicant
MACOMB CHEMICAL CO.
803 N. Front St. Suite 3
McHenry,  IL  60050
Correspondent
MACOMB CHEMICAL CO.
803 N. Front St. Suite 3
McHenry,  IL  60050
Regulation Number862.1345
Classification Product Code
CGA  
Date Received08/28/1979
Decision Date 09/24/1979
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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