PAXgene Blood DNA Tube— 510(k) K142821

Name: FDA 510(k) clearance K142821
Creator: U.S. Food and Drug Administration
Published: 2015-09-09

Substantially Equivalent

Preanalytix GmbH

FDA 510(k) clearance K142821 for PAXgene Blood DNA Tube, Substantially Equivalent on 2015-09-09. Applicant: Preanalytix GmbH. Device class: 2.

Clearance details

Applicant: Preanalytix GmbH
Product code: Code PJE
Device class: Class 2
Regulation: 21 CFR 862.1675
Advisory panel: Clinical Chemistry
Date received: 2014-09-30
Decision date: 2015-09-09
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Hombrechtikon, CH

Download summary PDF View on FDA.gov ↗

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Adverse events under product code PJE

product code PJE

Malfunction: 540
Total: 540

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.