FDA 510(k) Application Details - K133582

Device Classification Name	Plasma, Coagulation Control   More FDA Info for this Device
510(K) Number	K133582
Device Name	Plasma, Coagulation Control
Applicant	INSTRUMENTATION LABORATORY 180 HARTWELL RD BEDFORD, MA 01730 US Other 510(k) Applications for this Company
Contact	CAROL MARBLE Other 510(k) Applications for this Contact
Regulation Number	864.5425   More FDA Info for this Regulation Number
Classification Product Code	GGN Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	11/21/2013
Decision Date	08/15/2014
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	HE - Hematology
Review Advisory Committee	HE - Hematology
Statement / Summary / Purged Status	Statement
Type	Traditional
Reviewed By Third Party	N
Expedited Review