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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Hexokinase, Glucose
510(k) Number K120681
Device Name ADVIA CHEMISTRY GLUH_3 REAGENTS
Applicant
Siemens Healthcare Diagnostics, Inc.
511 Benedict Ave.
Tarrytown,  NY  10509
Applicant Contact KIRA GORDON
Correspondent
Siemens Healthcare Diagnostics, Inc.
511 Benedict Ave.
Tarrytown,  NY  10509
Correspondent Contact KIRA GORDON
Regulation Number862.1345
Classification Product Code
CFR  
Date Received03/06/2012
Decision Date 05/15/2012
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
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