FDA 510(k)

FluChip-8G Influenza A+B Assay

Número K: K182513 · 2019-04-22

Data da decisão2019-04-22

Código do produtoOZE

Comité consultivoMI

DecisãoSubstantially Equivalent

Resumo do dispositivo

FluChip-8G Influenza A+B Assay is the device name listed in this FDA 510(k) record. The listed applicant is Indevr, Inc.. It received FDA 510(k) clearance on 2019-04-22 under 510(k) number K182513. The device is classified under product code OZE. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the FluChip-8G Influenza A+B Assay?

FluChip-8G Influenza A+B Assay is a medical device that received FDA 510(k) clearance on 2019-04-22. The listed applicant is Indevr, Inc.. The 510(k) number is K182513.

When did FluChip-8G Influenza A+B Assay receive FDA 510(k) clearance?

FluChip-8G Influenza A+B Assay received FDA 510(k) clearance on 2019-04-22, under 510(k) number K182513.

Who is the listed applicant for FluChip-8G Influenza A+B Assay?

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

What is the FDA product code for FluChip-8G Influenza A+B Assay?

The FDA product code for FluChip-8G Influenza A+B Assay is OZE.

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