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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Blood/Plasma Collection Device For Dna Testing
510(k) Number K142821
Device Name PAXgene Blood DNA Tube
Applicant
Preanalytix GmbH
Feldbachstrasse
Hombrechtikon,  CH 8634
Applicant Contact Pasquale Amato
Correspondent
Preanalytix GmbH
Feldbachstrasse
Hombrechtikon,  CH 8634
Correspondent Contact Pasquale Amato
Regulation Number862.1675
Classification Product Code
PJE  
Date Received09/30/2014
Decision Date 09/09/2015
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Toxicology
Summary Summary
FDA Review Decision Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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