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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 K860682
Device Name GAMBRO ANALYZ MON GLUCOSE/AM-G & DISP AM-G TUB SET
Applicant
Gambro, Inc.
600 Knightsbridge Pkwy.
Lincolnshire,  IL  60069
Applicant Contact JEFFREY R SHIDEMAN
Correspondent
Gambro, Inc.
600 Knightsbridge Pkwy.
Lincolnshire,  IL  60069
Correspondent Contact JEFFREY R SHIDEMAN
Regulation Number862.1345
Classification Product Code
CGA  
Date Received02/25/1986
Decision Date 08/29/1986
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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