FDA 510(k) Application Details - K051633

Device Classification Name	Control, White-Cell   More FDA Info for this Device
510(K) Number	K051633
Device Name	Control, White-Cell
Applicant	Streck 7002 SOUTH 109TH ST. OMAHA, NE 68128 US Other 510(k) Applications for this Company
Contact	CAROL THOMPSON Other 510(k) Applications for this Contact
Regulation Number	864.8625   More FDA Info for this Regulation Number
Classification Product Code	GGL Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	06/20/2005
Decision Date	08/16/2005
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