FDA 510(k) Application Details - K082150

Device Classification Name	System, Blood Collection, Rna Stabilization, Rna Purification, Rt-Pcr Molecular Diagnostic Test   More FDA Info for this Device
510(K) Number	K082150
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	WENDY BALLESTEROS 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	07/30/2008
Decision Date	02/04/2009
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	IM - Immunology
Review Advisory Committee	PA - Pathology
Statement / Summary / Purged Status	Summary
Type	Special
Reviewed By Third Party	N
Expedited Review