INNOVANCE(r) Heparin Reagents, INNOVANCE(r) Heparin Calibrator, INNOVANCE(r) Heparin UF and Heparin LMW Controls— 510(k) K162540

Name: FDA 510(k) clearance K162540
Creator: U.S. Food and Drug Administration
Published: 2017-08-22

Substantially Equivalent

Siemens Healthcare Diagnostics Prodcts GmbH

FDA 510(k) clearance K162540 for INNOVANCE(r) Heparin Reagents, INNOVANCE(r) Heparin Calibrator, INNOVANCE(r) Heparin UF and Heparin LMW Controls, Substantially Equivalent on 2017-08-22. Applicant: Siemens Healthcare Diagnostics Prodcts GmbH. Device class: 2.

Clearance details

Applicant: Siemens Healthcare Diagnostics Prodcts GmbH
Product code: Code KFF
Device class: Class 2
Regulation: 21 CFR 864.7525
Advisory panel: Hematology
Date received: 2016-09-12
Decision date: 2017-08-22
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Marburg, DE

Download summary PDF View on FDA.gov ↗

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