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510(k) K103555

MULTIPLATE 5.0 AGGREGOMETER by Verum Diagnostica GmbH — Product Code JOZ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 27, 2012
Date Received
December 3, 2010
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
System, Automated Platelet Aggregation
Device Class
Class II
Regulation Number
864.5700
Review Panel
HE
Submission Type

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