FDA 510(k) Application Details - K972831

Device Classification Name	Activated Partial Thromboplastin   More FDA Info for this Device
510(K) Number	K972831
Device Name	Activated Partial Thromboplastin
Applicant	INTERNATIONAL TECHNIDYNE CORP. 8 OLSEN AVE. EDISON, NJ 08820 US Other 510(k) Applications for this Company
Contact	ROBERT H MATLAND 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	07/30/1997
Decision Date	11/20/1997
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	HE - Hematology
Review Advisory Committee	HE - Hematology
Statement / Summary / Purged Status	Statement
Type	Traditional
Reviewed By Third Party	N
Expedited Review