FDA 510(k) Application Details - K062306

Device Classification Name	Control, Plasma, Abnormal   More FDA Info for this Device
510(K) Number	K062306
Device Name	Control, Plasma, Abnormal
Applicant	R2 DIAGNOSTICS, INC. 1801 COMMERCE DR. SOUTH BEND, IN 46628 US Other 510(k) Applications for this Company
Contact	MARC GOLDFORD Other 510(k) Applications for this Contact
Regulation Number	864.5425   More FDA Info for this Regulation Number
Classification Product Code	GGC Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	08/08/2006
Decision Date	03/16/2007
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