FDA 510(k)

ST AIA-PACK BNP

Número K: K192380 · 2020-08-24

Data da decisão2020-08-24

Código do produtoNBC

Comité consultivoCH

DecisãoSubstantially Equivalent

Resumo do dispositivo

ST AIA-PACK BNP is the device name listed in this FDA 510(k) record. The listed applicant is Fujirebio Diagnostics,Inc.. It received FDA 510(k) clearance on 2020-08-24 under 510(k) number K192380. The device is classified under product code NBC. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the ST AIA-PACK BNP?

ST AIA-PACK BNP is a medical device that received FDA 510(k) clearance on 2020-08-24. The listed applicant is Fujirebio Diagnostics,Inc.. The 510(k) number is K192380.

When did ST AIA-PACK BNP receive FDA 510(k) clearance?

ST AIA-PACK BNP received FDA 510(k) clearance on 2020-08-24, under 510(k) number K192380.

Who is the listed applicant for ST AIA-PACK BNP?

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

What is the FDA product code for ST AIA-PACK BNP?

The FDA product code for ST AIA-PACK BNP is NBC.

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Fonte oficial

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