FDA 510(k) Application Details - K111822

Device Classification Name	Assay, Heparin   More FDA Info for this Device
510(K) Number	K111822
Device Name	Assay, Heparin
Applicant	DIAGNOSTICA STAGO, INC. PIAZZA ALBANIA, 10 ROME 00153 IT Other 510(k) Applications for this Company
Contact	CARLO D'ALESSANDRO Other 510(k) Applications for this Contact
Regulation Number	864.7525   More FDA Info for this Regulation Number
Classification Product Code	KFF Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	06/28/2011
Decision Date	10/26/2011
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