FDA 510(k) Application Details - K091303

Device Classification Name	Mixture, Hematology Quality Control   More FDA Info for this Device
510(K) Number	K091303
Device Name	Mixture, Hematology Quality Control
Applicant	Bio-Rad Laboratories 9500 JERONIMO RD. IRVINE, CA 92618-2017 US Other 510(k) Applications for this Company
Contact	SUZANNE S PARSONS 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	05/04/2009
Decision Date	08/02/2010
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