FDA 510(k) Application Details - K113211

Device Classification Name	Plasma, Coagulation Control   More FDA Info for this Device
510(K) Number	K113211
Device Name	Plasma, Coagulation Control
Applicant	INSTRUMENTATION LABORATORY CO. 180 HARTWELL ROAD BEDFORD, MA 01730 US Other 510(k) Applications for this Company
Contact	Jacqueline Emery 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	10/31/2011
Decision Date	01/04/2012
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