FDA 510(k) Application Details - K103555

Device Classification Name	System, Automated Platelet Aggregation   More FDA Info for this Device
510(K) Number	K103555
Device Name	System, Automated Platelet Aggregation
Applicant	VERUM DIAGNOSTICA GMBH REICHENBACHSTRASSE 27 MUNICH 80469 DE Other 510(k) Applications for this Company
Contact	MAXIMILIAN ZUCKER Other 510(k) Applications for this Contact
Regulation Number	864.5700   More FDA Info for this Regulation Number
Classification Product Code	JOZ Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	12/03/2010
Decision Date	07/27/2012
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	HE - Hematology
Review Advisory Committee	HE - Hematology
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review