FDA 510(k) Application Details - K062203

Device Classification Name	Fibrin Split Products   More FDA Info for this Device
510(K) Number	K062203
Device Name	Fibrin Split Products
Applicant	ROCHE DIAGNOSTICS CORP. 9115 HAGUE RD. INDIANAPOLIS, IN 46250 US Other 510(k) Applications for this Company
Contact	THERESA AMBROSE BUSH Other 510(k) Applications for this Contact
Regulation Number	864.7320   More FDA Info for this Regulation Number
Classification Product Code	GHH Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	08/01/2006
Decision Date	03/14/2007
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