FDA 510(k) Application Details - K160588

Device Classification Name	Mixture, Hematology Quality Control   More FDA Info for this Device
510(K) Number	K160588
Device Name	Mixture, Hematology Quality Control
Applicant	STRECK 7002 S. 109TH STREET LA VISTA, NE 68137 US Other 510(k) Applications for this Company
Contact	DEBORAH KIPP 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	03/01/2016
Decision Date	12/22/2016
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