FDA 510(k) Application Details - K981206

Device Classification Name	Instrument, Coagulation, Automated   More FDA Info for this Device
510(K) Number	K981206
Device Name	Instrument, Coagulation, Automated
Applicant	CARDIOVASCULAR DIAGNOSTICS, INC. 5301 DEPARTURE DR. RALEIGH, NC 27616 US Other 510(k) Applications for this Company
Contact	GREG GODLEVSKI Other 510(k) Applications for this Contact
Regulation Number	864.5400   More FDA Info for this Regulation Number
Classification Product Code	GKP Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	04/01/1998
Decision Date	05/26/1998
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