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FDA 510(k)

QIAstat-Dx Gastrointestinal Panel 2

K-Number: K220062 · 2024-05-31

ApplicantQIAGEN GmbH
Decision Date2024-05-31
Product CodePCH
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

QIAstat-Dx Gastrointestinal Panel 2 is a medical device manufactured by QIAGEN GmbH. It received FDA 510(k) clearance on 2024-05-31 under approval number K220062. The device is classified under product code PCH. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the QIAstat-Dx Gastrointestinal Panel 2?

QIAstat-Dx Gastrointestinal Panel 2 is a medical device that received FDA 510(k) clearance on 2024-05-31. It is manufactured by QIAGEN GmbH. The 510(k) number is K220062.

When was QIAstat-Dx Gastrointestinal Panel 2 approved by the FDA?

QIAstat-Dx Gastrointestinal Panel 2 received FDA 510(k) clearance on 2024-05-31, under approval number K220062.

What company makes QIAstat-Dx Gastrointestinal Panel 2?

QIAstat-Dx Gastrointestinal Panel 2 is manufactured by QIAGEN GmbH.

What is the FDA product code for QIAstat-Dx Gastrointestinal Panel 2?

The FDA product code for QIAstat-Dx Gastrointestinal Panel 2 is PCH.

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Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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