FDA 510(k) Applications for Medical Device Product Code "NTW"
(System, Blood Collection, Rna Stabilization, Rna Purification, Rt-Pcr Molecular Diagnostic Test)

FDA 510(k) Number Applicant Device Name Decision Date
K082150 PREANALYTIX GMBH MODIFICATION TO PAXGENE BLOOD RNA SYSTEM 02/04/2009
DEN050003 PREANALYTIX GMBH PAXGENE BLOOD RNA SYSTEM 04/18/2005


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