FDA 510(k) Application Details - K983649

Device Classification Name	Activated Whole Blood Clotting Time   More FDA Info for this Device
510(K) Number	K983649
Device Name	Activated Whole Blood Clotting Time
Applicant	ARRAY MEDICAL, INC. ONE HARVARD WAY, SUITE 5 HILLSBOROUGH CAMPUS SOMERVILLE, NJ 08876 US Other 510(k) Applications for this Company
Contact	MICHAEL F CORSELLO Other 510(k) Applications for this Contact
Regulation Number	864.7140   More FDA Info for this Regulation Number
Classification Product Code	JBP Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	10/16/1998
Decision Date	12/11/1998
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