FDA 510(k) Application Details - K102552

Device Classification Name	Control, Plasma, Abnormal   More FDA Info for this Device
510(K) Number	K102552
Device Name	Control, Plasma, Abnormal
Applicant	INSTRUMENTATION LABORATORY CO. 180 HARTWELL ROAD 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	GGC Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	09/07/2010
Decision Date	04/05/2011
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