FDA 510(k)

Idylla Respiratory (IFV-RSV) Panel

Número K: K163628 · 2017-08-30

Data da decisão2017-08-30

Código do produtoOCC

Comité consultivoMI

DecisãoSubstantially Equivalent

Resumo do dispositivo

Idylla Respiratory (IFV-RSV) Panel is the device name listed in this FDA 510(k) record. The listed applicant is Janssen Pharmaceutica NV. It received FDA 510(k) clearance on 2017-08-30 under 510(k) number K163628. 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 Idylla Respiratory (IFV-RSV) Panel?

Idylla Respiratory (IFV-RSV) Panel is a medical device that received FDA 510(k) clearance on 2017-08-30. The listed applicant is Janssen Pharmaceutica NV. The 510(k) number is K163628.

When did Idylla Respiratory (IFV-RSV) Panel receive FDA 510(k) clearance?

Idylla Respiratory (IFV-RSV) Panel received FDA 510(k) clearance on 2017-08-30, under 510(k) number K163628.

Who is the listed applicant for Idylla Respiratory (IFV-RSV) Panel?

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

What is the FDA product code for Idylla Respiratory (IFV-RSV) Panel?

The FDA product code for Idylla Respiratory (IFV-RSV) Panel is OCC.

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