FDA 510(k)

Simplexa Flu A/B & RSV Direct Gen II, Simplexa Flu A/B & RSV Positive Control Pack

Número K: K201505 · 2020-08-22

Data da decisão2020-08-22

Código do produtoOCC

Comité consultivoMI

DecisãoSubstantially Equivalent

Resumo do dispositivo

Simplexa Flu A/B & RSV Direct Gen II, Simplexa Flu A/B & RSV Positive Control Pack is the device name listed in this FDA 510(k) record. The listed applicant is Diasorin Molecular, LLC. It received FDA 510(k) clearance on 2020-08-22 under 510(k) number K201505. 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 Simplexa Flu A/B & RSV Direct Gen II, Simplexa Flu A/B & RSV Positive Control Pack?

Simplexa Flu A/B & RSV Direct Gen II, Simplexa Flu A/B & RSV Positive Control Pack is a medical device that received FDA 510(k) clearance on 2020-08-22. The listed applicant is Diasorin Molecular, LLC. The 510(k) number is K201505.

When did Simplexa Flu A/B & RSV Direct Gen II, Simplexa Flu A/B & RSV Positive Control Pack receive FDA 510(k) clearance?

Simplexa Flu A/B & RSV Direct Gen II, Simplexa Flu A/B & RSV Positive Control Pack received FDA 510(k) clearance on 2020-08-22, under 510(k) number K201505.

Who is the listed applicant for Simplexa Flu A/B & RSV Direct Gen II, Simplexa Flu A/B & RSV Positive Control Pack?

The FDA 510(k) record lists Diasorin Molecular, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Simplexa Flu A/B & RSV Direct Gen II, Simplexa Flu A/B & RSV Positive Control Pack?

The FDA product code for Simplexa Flu A/B & RSV Direct Gen II, Simplexa Flu A/B & RSV Positive Control Pack is OCC.

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