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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 K042015
Device Name ADVIA CHEMISTRY GLUCOSE OXIDASE ASSAY AND ADVIA CHEMISTRY GLUCOSE HEXOKINASE
Applicant
Bayer Healthcare, Diagnostics Division
511 Benedict Ave.
New York,  NY  10591
Applicant Contact ANDRES HOLLE
Correspondent
Bayer Healthcare, Diagnostics Division
511 Benedict Ave.
New York,  NY  10591
Correspondent Contact ANDRES HOLLE
Regulation Number862.1345
Classification Product Code
CGA  
Subsequent Product Code
CFR  
Date Received07/27/2004
Decision Date 09/29/2004
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
Summary Summary
FDA Review Decision Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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