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510(k) K101854

ADVIA CHEMISTRY GLUCOSE HEXOKINASE_3 (GLUH_3) REAGENT, MODELS REF 05001429 by Siemens Healthcare Diagnostics — Product Code CFR

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 7, 2011
Date Received
July 1, 2010
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Hexokinase, Glucose
Device Class
Class II
Regulation Number
862.1345
Review Panel
CH
Submission Type

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