FDA 510(k) Application Details - K964609

Device Classification Name	Activated Whole Blood Clotting Time   More FDA Info for this Device
510(K) Number	K964609
Device Name	Activated Whole Blood Clotting Time
Applicant	ARRAY MEDICAL, INC. 245 RT. 22 WEST BRIDGEWATER, NJ 08807 US Other 510(k) Applications for this Company
Contact	PATRICIA E BONNESS 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	11/18/1996
Decision Date	03/06/1997
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