FDA 510(k)

Vstrip H. pylori Antigen Rapid Test

Número K: K183573 · 2019-03-14

Data da decisão2019-03-14

Código do produtoLYR

Comité consultivoMI

DecisãoSubstantially Equivalent

Resumo do dispositivo

Vstrip H. pylori Antigen Rapid Test is the device name listed in this FDA 510(k) record. The listed applicant is Panion & BF Biotech, Inc.. It received FDA 510(k) clearance on 2019-03-14 under 510(k) number K183573. The device is classified under product code LYR. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the Vstrip H. pylori Antigen Rapid Test?

Vstrip H. pylori Antigen Rapid Test is a medical device that received FDA 510(k) clearance on 2019-03-14. The listed applicant is Panion & BF Biotech, Inc.. The 510(k) number is K183573.

When did Vstrip H. pylori Antigen Rapid Test receive FDA 510(k) clearance?

Vstrip H. pylori Antigen Rapid Test received FDA 510(k) clearance on 2019-03-14, under 510(k) number K183573.

Who is the listed applicant for Vstrip H. pylori Antigen Rapid Test?

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

What is the FDA product code for Vstrip H. pylori Antigen Rapid Test?

The FDA product code for Vstrip H. pylori Antigen Rapid Test is LYR.

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