FDA 510(k) Application Details - K161329

Device Classification Name	System, Automated Platelet Aggregation   More FDA Info for this Device
510(K) Number	K161329
Device Name	System, Automated Platelet Aggregation
Applicant	Chrono-log Corp. 2 West Park Road Havertown, PA 19083 US Other 510(k) Applications for this Company
Contact	Nicholas J Veriabo 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	05/12/2016
Decision Date	12/02/2016
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	HE - Hematology
Review Advisory Committee	HE - Hematology
Statement / Summary / Purged Status	Summary
Type	Special
Reviewed By Third Party	N
Expedited Review