K162540

Substantially Equivalent

INNOVANCE(r) Heparin Reagents, INNOVANCE(r) Heparin Calibrator, INNOVANCE(r) Heparin UF and Heparin LMW Controls

Applicant: Siemens Healthcare Diagnostics Prodcts GmbH
Product code: KFF
Advisory panel: Hematology
Date received: 2016-09-12
Decision date: 2017-08-22
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Marburg, DE

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