FDA 510(k) Application Details - K983475

Device Classification Name	Instrument, Coagulation   More FDA Info for this Device
510(K) Number	K983475
Device Name	Instrument, Coagulation
Applicant	INTERNATIONAL TECHNIDYNE CORP. 8 OLSEN AVE. EDISON, NJ 08820 US Other 510(k) Applications for this Company
Contact	JOHN M CLAY Other 510(k) Applications for this Contact
Regulation Number	864.5400   More FDA Info for this Regulation Number
Classification Product Code	KQG Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	10/02/1998
Decision Date	05/03/1999
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