ADVIA CHEMISTRY GLUCOSE HEXOKINASE_3 (GLUH_3) REAGENT, MODELS REF 05001429— 510(k) K101854

Name: FDA 510(k) clearance K101854
Creator: U.S. Food and Drug Administration
Published: 2011-03-07

Substantially Equivalent

Siemens Healthcare Diagnostics

FDA 510(k) clearance K101854 for ADVIA CHEMISTRY GLUCOSE HEXOKINASE_3 (GLUH_3) REAGENT, MODELS REF 05001429, Substantially Equivalent on 2011-03-07. Applicant: Siemens Healthcare Diagnostics. Device class: 2.

Clearance details

Applicant: Siemens Healthcare Diagnostics
Product code: Code CFR
Device class: Class 2
Regulation: 21 CFR 862.1345
Advisory panel: Clinical Chemistry
Date received: 2010-07-01
Decision date: 2011-03-07
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Tarrytown, NY, US

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