ROTOR-GENE Q MDX— 510(k) K113319

Substantially Equivalent

QIAGEN GmbH

FDA 510(k) clearance K113319 for ROTOR-GENE Q MDX, Substantially Equivalent on 2012-02-06. Applicant: QIAGEN GmbH.

Clearance details

Applicant: QIAGEN GmbH
Product code: Code OOI
Advisory panel: Clinical Chemistry
Date received: 2011-11-10
Decision date: 2012-02-06
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Gaithersburg, MD, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code OOI

product code OOI

Malfunction: 2,506
Other: 3
Total: 2,509

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.