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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 K801897
Device Name GLUCOSE DIAGNOSTIC REAGENT
Applicant
CONNECTICUT DIAGNOSTICS, LTD.
803 N. Front St. Suite 3
McHenry,  IL  60050
Correspondent
CONNECTICUT DIAGNOSTICS, LTD.
803 N. Front St. Suite 3
McHenry,  IL  60050
Regulation Number862.1345
Classification Product Code
CGA  
Date Received08/08/1980
Decision Date 10/10/1980
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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