FDA 510(k) Application Details - K071041

Device Classification Name	Test, Time, Prothrombin   More FDA Info for this Device
510(K) Number	K071041
Device Name	Test, Time, Prothrombin
Applicant	Roche Diagnostics 9115 HAGUE ROAD INDIANAPOLIS, IN 46250-0416 US Other 510(k) Applications for this Company
Contact	THERESA BUSH Other 510(k) Applications for this Contact
Regulation Number	864.7750   More FDA Info for this Regulation Number
Classification Product Code	GJS Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	04/12/2007
Decision Date	05/11/2007
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	HE - Hematology
Review Advisory Committee	HE - Hematology
Statement / Summary / Purged Status	Summary
Type	Special
Reviewed By Third Party	N
Expedited Review