FDA 510(k) Application Details - K955843

Device Classification Name	Test, Time, Prothrombin   More FDA Info for this Device
510(K) Number	K955843
Device Name	Test, Time, Prothrombin
Applicant	CARDIOVASCULAR DIAGNOSTIC SERVICES 5301 DEPARTURE DR. RALEIGH, NC 27604 US Other 510(k) Applications for this Company
Contact	CYNTHIA PRITCHARD, PH.D. Other 510(k) Applications for this Contact
Regulation Number	864.7750   More FDA Info for this Regulation Number
Classification Product Code	GJS Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	12/26/1995
Decision Date	03/18/1996
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