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FDA 510(k)

QIAstat-Dx Respiratory Panel

K-Number: K183597 · 2019-05-18

ApplicantQIAGEN GmbH
Decision Date2019-05-18
Product CodeOCC
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

QIAstat-Dx Respiratory Panel is a medical device manufactured by QIAGEN GmbH. It received FDA 510(k) clearance on 2019-05-18 under approval number K183597. The device is classified under product code OCC. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the QIAstat-Dx Respiratory Panel?

QIAstat-Dx Respiratory Panel is a medical device that received FDA 510(k) clearance on 2019-05-18. It is manufactured by QIAGEN GmbH. The 510(k) number is K183597.

When was QIAstat-Dx Respiratory Panel approved by the FDA?

QIAstat-Dx Respiratory Panel received FDA 510(k) clearance on 2019-05-18, under approval number K183597.

What company makes QIAstat-Dx Respiratory Panel?

QIAstat-Dx Respiratory Panel is manufactured by QIAGEN GmbH.

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

The FDA product code for QIAstat-Dx Respiratory Panel is OCC.

Other Devices by QIAGEN GmbH

K242256QIAstat-Dx Meningitis/Encephalitis (ME) Panel K242353QIAstat-Dx Respiratory Panel Mini K220062QIAstat-Dx Gastrointestinal Panel 2 K233100QIAstat-Dx® Respiratory Panel Plus K252329QIAstat-Dx Gastrointestinal Panel 2; QIAstat-Dx GI Panel 2 Mini B&V; QIAstat-Dx GI Panel 2 Mini B K250080QIAstat-Dx Respiratory Panel Plus; QIAstat-Dx Respiratory Panel Mini

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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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