FDA 510(k) Application Details - K053497

Device Classification Name	Counter, Differential Cell   More FDA Info for this Device
510(K) Number	K053497
Device Name	Counter, Differential Cell
Applicant	GUAVA TECHNOLOGIES, INC. 25801 INDUSTRIAL BLVD. HAYWARD, CA 94545 US Other 510(k) Applications for this Company
Contact	LAWRENCE F BRUDER 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	12/15/2005
Decision Date	04/14/2006
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