QIAstat-Dx GI Panel 2 Mini B&V— 510(k) K243813

Substantially Equivalent

QIAGEN GmbH

FDA 510(k) clearance K243813 for QIAstat-Dx GI Panel 2 Mini B&V, Substantially Equivalent on 2025-01-08. 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: 2024-12-11
Decision date: 2025-01-08
Decision: Substantially Equivalent
Clearance type: Special
Location: Hilden, DE

Download summary PDF View on FDA.gov ↗

Recent devices under product code PCH

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K251721 — Xpert GI Panel2026-01-16
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K251868 — Panther Fusion GI Bacterial Assay2025-09-25

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K250324 — QIAstat-Dx GI Panel 2 Mini B2025-02-28
K242256 — QIAstat-Dx Meningitis/Encephalitis (ME) Panel2024-10-29
K242353 — QIAstat-Dx Respiratory Panel Mini2024-10-25

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