FDA 510(k) Application Details - K974566

Device Classification Name	Test, Time, Prothrombin   More FDA Info for this Device
510(K) Number	K974566
Device Name	Test, Time, Prothrombin
Applicant	ORGANON TEKNIKA CORP. 100 AKZO AVE. DURHAM, NC 27712 US Other 510(k) Applications for this Company
Contact	REBECCA A RIVAS 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	12/05/1997
Decision Date	02/24/1998
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