QIAstat-Dx Gastrointestinal Panel 2— 510(k) K220062

Name: FDA 510(k) clearance K220062
Creator: U.S. Food and Drug Administration
Published: 2024-05-31

Substantially Equivalent

QIAGEN GmbH

FDA 510(k) clearance K220062 for QIAstat-Dx Gastrointestinal Panel 2, Substantially Equivalent on 2024-05-31. Applicant: QIAGEN GmbH. Device class: 2.

Clearance details

Applicant: QIAGEN GmbH
Product code: Code PCH
Device class: Class 2
Regulation: 21 CFR 866.3990
Advisory panel: Microbiology
Date received: 2022-01-10
Decision date: 2024-05-31
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Hilden, DE

Download summary PDF View on FDA.gov ↗

Recent devices under product code PCH

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K253722 — LIAISON PLEX Gastrointestinal Flex Assay2026-05-19
K254032 — QIAstat-Dx Gastrointestinal Panel 2; QIAstat-Dx GI Panel 2 Mini B&V2026-03-09
K251721 — Xpert GI Panel2026-01-16
K252329 — QIAstat-Dx Gastrointestinal Panel 2; QIAstat-Dx GI Panel 2 Mini B&V2025-10-22
K251868 — Panther Fusion GI Bacterial Assay2025-09-25

More clearances from QIAGEN GmbH

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K254194 — QIAstat-Dx BCID GPF Plus AMR Panel2026-08-06
K250080 — QIAstat-Dx Respiratory Panel Plus; QIAstat-Dx Respiratory Panel Mini2025-08-27
K250324 — QIAstat-Dx GI Panel 2 Mini B2025-02-28
K243813 — QIAstat-Dx GI Panel 2 Mini B&V2025-01-08
K242256 — QIAstat-Dx Meningitis/Encephalitis (ME) Panel2024-10-29

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