FDA 510(k) Application Details - K060968

Device Classification Name	Plasma, Control, Normal   More FDA Info for this Device
510(K) Number	K060968
Device Name	Plasma, Control, Normal
Applicant	WORTHAM LABORATORIES INC 6340 BONNY OAKS DR. CHATTANOOGA, TN 37416 US Other 510(k) Applications for this Company
Contact	LEON WORTHAM Other 510(k) Applications for this Contact
Regulation Number	864.5425   More FDA Info for this Regulation Number
Classification Product Code	GIZ Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	04/07/2006
Decision Date	05/15/2007
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