FDA 510(k) Application Details - K991101

Device Classification Name	Instrument, Coagulation, Automated   More FDA Info for this Device
510(K) Number	K991101
Device Name	Instrument, Coagulation, Automated
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	864.5400   More FDA Info for this Regulation Number
Classification Product Code	GKP Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	04/01/1999
Decision Date	06/01/1999
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