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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 K101854
Device Name ADVIA CHEMISTRY GLUCOSE HEXOKINASE_3 (GLUH_3) REAGENT, MODELS REF 05001429
Applicant
SIEMENS HEALTHCARE DIAGNOSTICS
511 benedict Avenue
Tarrytown,  NY  10591
Applicant Contact KIRA GORDON
Correspondent
SIEMENS HEALTHCARE DIAGNOSTICS
511 benedict Avenue
Tarrytown,  NY  10591
Correspondent Contact KIRA GORDON
Regulation Number862.1345
Classification Product Code
CFR  
Date Received07/01/2010
Decision Date 03/07/2011
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
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