FDA 510(k) Application Details - K160445

Device Classification Name	Activated Partial Thromboplastin   More FDA Info for this Device
510(K) Number	K160445
Device Name	Activated Partial Thromboplastin
Applicant	INSTRUMENTATION LABORATORY CO. 180 HARTWELL ROAD BEDFORD, MA 01730-2442 US Other 510(k) Applications for this Company
Contact	Heather L Harvey Other 510(k) Applications for this Contact
Regulation Number	864.7925   More FDA Info for this Regulation Number
Classification Product Code	GFO Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	02/17/2016
Decision Date	03/16/2016
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