FDA 510(k) Application Details - K014008

Device Classification Name	Activated Partial Thromboplastin   More FDA Info for this Device
510(K) Number	K014008
Device Name	Activated Partial Thromboplastin
Applicant	ITC, INC. 8 OLSEN AVE. EDISON, NJ 08820 US Other 510(k) Applications for this Company
Contact	JOHN CLAY 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	12/05/2001
Decision Date	01/24/2002
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	HE - Hematology
Review Advisory Committee	HE - Hematology
Statement / Summary / Purged Status	Summary
Type	Special
Reviewed By Third Party	N
Expedited Review