MODIFICATION TO PAXGENE BLOOD RNA SYSTEM— 510(k) K082150

Name: FDA 510(k) clearance K082150
Creator: U.S. Food and Drug Administration
Published: 2009-02-04

Substantially Equivalent

Preanalytix GmbH

FDA 510(k) clearance K082150 for MODIFICATION TO PAXGENE BLOOD RNA SYSTEM, Substantially Equivalent on 2009-02-04. Applicant: Preanalytix GmbH. Device class: 2.

Clearance details

Applicant: Preanalytix GmbH
Product code: Code NTW
Device class: Class 2
Regulation: 21 CFR 866.4070
Advisory panel: Immunology
Date received: 2008-07-30
Decision date: 2009-02-04
Decision: Substantially Equivalent
Clearance type: Special
Location: Franklin Lakes, NJ, US

Download summary PDF View on FDA.gov ↗

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