FDA 510(k) Application Details - K160276

Device Classification Name	Instrument, Coagulation, Automated   More FDA Info for this Device
510(K) Number	K160276
Device Name	Instrument, Coagulation, Automated
Applicant	INSTRUMENTATION LABORATORY CO. 180 HARTWELL ROAD BEDFORD, MA 01730-2441 US Other 510(k) Applications for this Company
Contact	NIKITA MALLADI Other 510(k) Applications for this Contact
Regulation Number	864.5400   More FDA Info for this Regulation Number
Classification Product Code	GKP Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	02/02/2016
Decision Date	03/03/2016
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