FDA 510(k) Application Details - K961892

Device Classification Name	Activated Partial Thromboplastin   More FDA Info for this Device
510(K) Number	K961892
Device Name	Activated Partial Thromboplastin
Applicant	ANALYTICAL CONTROL SYSTEMS, INC. 9058 TECHNOLOGY DR. FISHERS, IN 46038 US Other 510(k) Applications for this Company
Contact	PAULINE W BONDERMAN 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	05/16/1996
Decision Date	03/07/1997
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