FDA 510(k) Application Details - K122162

Device Classification Name	System, Automated Platelet Aggregation   More FDA Info for this Device
510(K) Number	K122162
Device Name	System, Automated Platelet Aggregation
Applicant	AGGREDYNE, INC. 11874 SOUTH EVELYN CIRCLE HOUSTON, TX 77071 US Other 510(k) Applications for this Company
Contact	J. HARBEY KNAUSS 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	07/20/2012
Decision Date	12/20/2013
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