FDA 510(k) Application Details - K013305

Device Classification Name	Assay, Heparin   More FDA Info for this Device
510(K) Number	K013305
Device Name	Assay, Heparin
Applicant	CARDIOVASCULAR DIAGNOSTICS, INC. 9401 GLOBE CENTER DR. SUITE 140 MORRISVILLE, NC 27560 US Other 510(k) Applications for this Company
Contact	PETER SCOTT 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	10/04/2001
Decision Date	08/23/2002
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