FDA 510(k) Application Details - DEN050003

Device Classification Name	System, Blood Collection, Rna Stabilization, Rna Purification, Rt-Pcr Molecular Diagnostic Test   More FDA Info for this Device
510(K) Number	DEN050003
Device Name	System, Blood Collection, Rna Stabilization, Rna Purification, Rt-Pcr Molecular Diagnostic Test
Applicant	PREANALYTIX GMBH 1 BECTON DRIVE MC 300 FRANKLIN LAKES, NJ 07417 US Other 510(k) Applications for this Company
Contact	JING ZHANG Other 510(k) Applications for this Contact
Regulation Number	866.4070   More FDA Info for this Regulation Number
Classification Product Code	NTW Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	02/28/2005
Decision Date	04/18/2005
Decision	DENG -
Classification Advisory Committee	IM - Immunology
Review Advisory Committee	PA - Pathology
Statement / Summary / Purged Status
Type	Post-NSE
Reviewed By Third Party	N
Expedited Review