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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, Blood Collection, Rna Stabilization, Rna Purification, Rt-Pcr Molecular Diagnostic Test
510(k) Number K082150
Device Name MODIFICATION TO PAXGENE BLOOD RNA SYSTEM
Applicant
Preanalytix GmbH
1 Becton Dr.
Mc 300
Franklin Lakes,  NJ  07417
Applicant Contact WENDY BALLESTEROS
Correspondent
Preanalytix GmbH
1 Becton Dr.
Mc 300
Franklin Lakes,  NJ  07417
Correspondent Contact WENDY BALLESTEROS
Regulation Number866.4070
Classification Product Code
NTW  
Date Received07/30/2008
Decision Date 02/04/2009
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Immunology
510k Review Panel Pathology
Summary Summary
FDA Review Decision Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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