FDA 510(k) Application Details - K160415

Device Classification Name	Instrument, Hematocrit, Automated   More FDA Info for this Device
510(K) Number	K160415
Device Name	Instrument, Hematocrit, Automated
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	864.5600   More FDA Info for this Regulation Number
Classification Product Code	GKF Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	02/12/2016
Decision Date	12/14/2016
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	HE - Hematology
Review Advisory Committee	CH - Clinical Chemistry
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review