FDA 510(k)

EntericBio Dx Assay

Número K: K182703 · 2019-06-19

Data da decisão2019-06-19

Código do produtoPCH

Comité consultivoMI

DecisãoSubstantially Equivalent

Resumo do dispositivo

EntericBio Dx Assay is the device name listed in this FDA 510(k) record. The listed applicant is Serosep , Ltd.. It received FDA 510(k) clearance on 2019-06-19 under 510(k) number K182703. The device is classified under product code PCH. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the EntericBio Dx Assay?

EntericBio Dx Assay is a medical device that received FDA 510(k) clearance on 2019-06-19. The listed applicant is Serosep , Ltd.. The 510(k) number is K182703.

When did EntericBio Dx Assay receive FDA 510(k) clearance?

EntericBio Dx Assay received FDA 510(k) clearance on 2019-06-19, under 510(k) number K182703.

Who is the listed applicant for EntericBio Dx Assay?

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

What is the FDA product code for EntericBio Dx Assay?

The FDA product code for EntericBio Dx Assay is PCH.

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