FDA 510(k) Application Details - K160606

Device Classification Name	Mixture, Hematology Quality Control   More FDA Info for this Device
510(K) Number	K160606
Device Name	Mixture, Hematology Quality Control
Applicant	R & D SYSTEMS, INC. 614 MCKINLEY ST NE MINNEAPOLIS, MN 55413 US Other 510(k) Applications for this Company
Contact	RAVI KOMMINENI Other 510(k) Applications for this Contact
Regulation Number	864.8625   More FDA Info for this Regulation Number
Classification Product Code	JPK Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	03/02/2016
Decision Date	09/01/2016
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