FDA 510(k) Application Details - K961189

Device Classification Name	Plasma, Coagulation Control   More FDA Info for this Device
510(K) Number	K961189
Device Name	Plasma, Coagulation Control
Applicant	CARDIOVASCULAR DIAGNOSTICS, INC. 5301 DEPARTURE DR. RALEIGH, NC 27616 US Other 510(k) Applications for this Company
Contact	James M Clinton Other 510(k) Applications for this Contact
Regulation Number	864.5425   More FDA Info for this Regulation Number
Classification Product Code	GGN Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	03/26/1996
Decision Date	06/05/1996
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