FDA 510(k) Application Details - K072920

Device Classification Name	Test, Time, Prothrombin   More FDA Info for this Device
510(K) Number	K072920
Device Name	Test, Time, Prothrombin
Applicant	ROCHE DIAGNOSTICS CORP. 9115 HAGUE RD. INDIANAPOLIS, IN 46250 US Other 510(k) Applications for this Company
Contact	JASON FISHER 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	10/15/2007
Decision Date	01/31/2008
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	HE - Hematology
Review Advisory Committee	HE - Hematology
Statement / Summary / Purged Status	Summary
Type	Abbreviated
Reviewed By Third Party	N
Expedited Review