QIAstat-Dx Respiratory Panel— 510(k) K183597

Substantially Equivalent

QIAGEN GmbH

FDA 510(k) clearance K183597 for QIAstat-Dx Respiratory Panel, Substantially Equivalent on 2019-05-18. Applicant: QIAGEN GmbH.

Clearance details

Applicant: QIAGEN GmbH
Product code: Code OCC
Advisory panel: Microbiology
Date received: 2018-12-21
Decision date: 2019-05-18
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Hilden, DE

Download summary PDF View on FDA.gov ↗

Adverse events under product code OCC

product code OCC

Death: 3
Malfunction: 706
Total: 709

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.