QIAstat-Dx® Respiratory Panel Plus— 510(k) K233100

Substantially Equivalent

QIAGEN GmbH

FDA 510(k) clearance K233100 for QIAstat-Dx® Respiratory Panel Plus, Substantially Equivalent on 2024-05-10. 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: 2023-09-26
Decision date: 2024-05-10
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Hilden, DE

Download summary PDF View on FDA.gov ↗

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More clearances from QIAGEN GmbH

Recalls naming K233100

K-number listed on FDA's recall record

Z-1504-2025 — Brand Name: QIAstat-Dx Product Name: QIAstat-Dx Respiratory Panel Plus Reference Number (REF): 691224 Software Version: n/a Component: n/aClass II·Ongoing·Qiagen Sciences LLC·20250312

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K233100.

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