FDA 510(k) Application Details - K990566

Device Classification Name	System, Multipurpose For In Vitro Coagulation Studies   More FDA Info for this Device
510(K) Number	K990566
Device Name	System, Multipurpose For In Vitro Coagulation Studies
Applicant	CARDIOVASCULAR DIAGNOSTICS, INC. 5301 DEPARTURE DR. RALEIGH, NC 27616 US Other 510(k) Applications for this Company
Contact	PETER SCOTT Other 510(k) Applications for this Contact
Regulation Number	864.5425   More FDA Info for this Regulation Number
Classification Product Code	JPA Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	02/22/1999
Decision Date	05/14/1999
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