MODIFICATION TO PAXGENE BLOOD RNA SYSTEM

System, Blood Collection, Rna Stabilization, Rna Purification, Rt-pcr Molecular Diagnostic Test

PREANALYTIX GMBH

The following data is part of a premarket notification filed by Preanalytix Gmbh with the FDA for Modification To Paxgene Blood Rna System.

Pre-market Notification Details

Device IDK082150
510k NumberK082150
Device Name:MODIFICATION TO PAXGENE BLOOD RNA SYSTEM
ClassificationSystem, Blood Collection, Rna Stabilization, Rna Purification, Rt-pcr Molecular Diagnostic Test
Applicant PREANALYTIX GMBH 1 BECTON DRIVE MC 300 Franklin Lakes,  NJ  07417
ContactWendy Ballesteros
CorrespondentWendy Ballesteros
PREANALYTIX GMBH 1 BECTON DRIVE MC 300 Franklin Lakes,  NJ  07417
Product CodeNTW  
CFR Regulation Number866.4070 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2008-07-30
Decision Date2009-02-04
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
54053727621653 K082150 000
04053727621658 K082150 000

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