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510(k) K082150

MODIFICATION TO PAXGENE BLOOD RNA SYSTEM by Preanalytix GmbH — Product Code NTW

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 4, 2009
Date Received
July 30, 2008
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
System, Blood Collection, Rna Stabilization, Rna Purification, Rt-Pcr Molecular Diagnostic Test
Device Class
Class II
Regulation Number
866.4070
Review Panel
PA
Submission Type

System for collection, storage, and transport of whole blood and stabilization of intracellular rna with subsequent isolation and purification of host rna for rt-pcr used in molecular diagnostic testing

Other clearances by Preanalytix GmbH

  • K231469 — PAXgene® Blood DNA Tube (June 21, 2023)
  • K142821 — PAXgene Blood DNA Tube (September 9, 2015)
  • DEN050003 — PAXGENE BLOOD RNA SYSTEM (April 18, 2005)

Other clearances for product code NTW

  • DEN050003 — PAXGENE BLOOD RNA SYSTEM (April 18, 2005)