MULTIPLATE 5.0 AGGREGOMETER— 510(k) K103555

Name: FDA 510(k) clearance K103555
Creator: U.S. Food and Drug Administration
Published: 2012-07-27

Substantially Equivalent

Verum Diagnostica GmbH

FDA 510(k) clearance K103555 for MULTIPLATE 5.0 AGGREGOMETER, Substantially Equivalent on 2012-07-27. Applicant: Verum Diagnostica GmbH. Device class: 2.

Clearance details

Applicant: Verum Diagnostica GmbH
Product code: Code JOZ
Device class: Class 2
Regulation: 21 CFR 864.5700
Advisory panel: Hematology
Date received: 2010-12-03
Decision date: 2012-07-27
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Munich, DE

Download summary PDF View on FDA.gov ↗

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