FDA 510(k)

QIAstat-Dx Respiratory Panel

Número K: K183597 · 2019-05-18

Data da decisão2019-05-18

Código do produtoOCC

Comité consultivoMI

DecisãoSubstantially Equivalent

Resumo do dispositivo

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

Perguntas frequentes

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. The listed applicant is QIAGEN GmbH. The 510(k) number is K183597.

When did QIAstat-Dx Respiratory Panel receive FDA 510(k) clearance?

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

Who is the listed applicant for QIAstat-Dx Respiratory Panel?

The FDA 510(k) record lists QIAGEN GmbH as the applicant. This does not by itself establish the device manufacturer.

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

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

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Outros registros que listam QIAGEN GmbH como candidato(a)

K262168QIAstat-Dx BCID GN Plus AMR Panel K254194QIAstat-Dx BCID GPF Plus AMR Panel K254032QIAstat-Dx Gastrointestinal Panel 2; QIAstat-Dx GI Panel 2 Mini B&V; QIAstat-Dx GI Panel 2 Mini B 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 K250324QIAstat-Dx GI Panel 2 Mini B

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Fonte oficial

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