510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K082150Substantially Equivalent

Modification to Paxgene Blood RNA System

Preanalytix GmbH, Franklin Lakes NJ / Special, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K082150 is the FDA 510(k) clearance record for MODIFICATION TO PAXGENE BLOOD RNA SYSTEM, a class II device, cleared for Preanalytix GmbH on under FDA product code NTW (System, Blood Collection, Rna Stabilization, Rna Purification, Rt-Pcr Molecular Diagnostic Test). FDA's definition for product code NTW reads: "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". FDA records list 4 510(k) clearances for Preanalytix GmbH, from to . As of , FDA records show no recalls naming K082150.

Clearance record

Decision date
Received
(189 days to decision)
Product code
NTW System, Blood Collection, Rna Stabilization, Rna Purification, Rt-Pcr Molecular Diagnostic Test
Regulation
21 CFR 866.4070
Device class
Class II
Review panel
Immunology
Applicant
Preanalytix GmbH 1 Becton Dr., Franklin Lakes NJ
510(k) summary
Summary PDF
Third party review
No

Clearances, product code NTW

Trailing 12 months

FDA records hold no clearances under product code NTW in the trailing twelve months.

FDA records show no clearances under product code NTW in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code NTW, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260