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510(k) K162540

INNOVANCE(r) Heparin Reagents, INNOVANCE(r) Heparin Calibrator, INNOVANCE(r) Heparin UF and Heparin LMW Controls by Siemens Healthcare Diagnostics Prodcts GmbH — Product Code KFF

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 22, 2017
Date Received
September 12, 2016
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Assay, Heparin
Device Class
Class II
Regulation Number
864.7525
Review Panel
HE
Submission Type

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