FDA 510(k) Application Details - K093394

Device Classification Name	Counter, Differential Cell   More FDA Info for this Device
510(K) Number	K093394
Device Name	Counter, Differential Cell
Applicant	SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO., LTD 55 NORTHERN BLVD., SUITE 200 GREAT NECK, NY 11021 US Other 510(k) Applications for this Company
Contact	SUSAN GOLDSTEIN Other 510(k) Applications for this Contact
Regulation Number	864.5220   More FDA Info for this Regulation Number
Classification Product Code	GKZ Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	10/30/2009
Decision Date	04/08/2010
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