PAXgene Blood DNA Tube

Blood/plasma Collection Device For Dna Testing

PREANALYTIX GMBH

The following data is part of a premarket notification filed by Preanalytix Gmbh with the FDA for Paxgene Blood Dna Tube.

Pre-market Notification Details

Device IDK142821
510k NumberK142821
Device Name:PAXgene Blood DNA Tube
ClassificationBlood/plasma Collection Device For Dna Testing
Applicant PREANALYTIX GMBH FELDBACHSTRASSE Hombrechtikon,  CH 8634
ContactPasquale Amato
CorrespondentPasquale Amato
PREANALYTIX GMBH FELDBACHSTRASSE Hombrechtikon,  CH 8634
Product CodePJE  
CFR Regulation Number862.1675 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2014-09-30
Decision Date2015-09-09
Summary:summary

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