FDA 510(k) Application Details - K053111

Device Classification Name	Activated Partial Thromboplastin   More FDA Info for this Device
510(K) Number	K053111
Device Name	Activated Partial Thromboplastin
Applicant	DIAGNOSTICA STAGO, INC. 5 CENTURY DR. PARSIPPANY, NJ 07054 US Other 510(k) Applications for this Company
Contact	JIM BARROW Other 510(k) Applications for this Contact
Regulation Number	864.7925   More FDA Info for this Regulation Number
Classification Product Code	GFO Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	11/04/2005
Decision Date	05/04/2006
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