QIAstat-Dx Respiratory Panel Plus; QIAstat-Dx Respiratory Panel Mini— 510(k) K250080

Name: FDA 510(k) clearance K250080
Creator: U.S. Food and Drug Administration
Published: 2025-08-27

Substantially Equivalent

QIAGEN GmbH

FDA 510(k) clearance K250080 for QIAstat-Dx Respiratory Panel Plus; QIAstat-Dx Respiratory Panel Mini, Substantially Equivalent on 2025-08-27. Applicant: QIAGEN GmbH. Device class: 2.

Clearance details

Applicant: QIAGEN GmbH
Product code: Code QOF
Device class: Class 2
Regulation: 21 CFR 866.3981
Advisory panel: Microbiology
Date received: 2025-01-13
Decision date: 2025-08-27
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Hilden, DE

Download summary PDF View on FDA.gov ↗

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K251978 — LIAISON NES FLU A/B, RSV & COVID-192025-12-23

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K252329 — QIAstat-Dx Gastrointestinal Panel 2; QIAstat-Dx GI Panel 2 Mini B&V2025-10-22
K250324 — QIAstat-Dx GI Panel 2 Mini B2025-02-28
K243813 — QIAstat-Dx GI Panel 2 Mini B&V2025-01-08

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