FDA 510(k) Application Details - K964934

Device Classification Name	Prothrombin Fragment 1.2   More FDA Info for this Device
510(K) Number	K964934
Device Name	Prothrombin Fragment 1.2
Applicant	ORGANON TEKNIKA CORP. 100 AKZO AVE. DURHAM, NC 27712 US Other 510(k) Applications for this Company
Contact	RON SANYAL Other 510(k) Applications for this Contact
Regulation Number	864.7320   More FDA Info for this Regulation Number
Classification Product Code	MIF Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	12/09/1996
Decision Date	03/18/1997
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