ADVIA CHEMISTRY GLUH_3 REAGENTS— 510(k) K120681

Substantially Equivalent

Siemens Healthcare Diagnostics, Inc.

FDA 510(k) clearance K120681 for ADVIA CHEMISTRY GLUH_3 REAGENTS, Substantially Equivalent on 2012-05-15. Applicant: Siemens Healthcare Diagnostics, Inc..

Clearance details

Applicant: Siemens Healthcare Diagnostics, Inc.
Product code: Code CFR
Advisory panel: Clinical Chemistry
Date received: 2012-03-06
Decision date: 2012-05-15
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Tarrytown, NY, US

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