FDA 510(k)

Hp Detect™ Stool Antigen ELISA

Número K: K232892 · 2023-12-15

Data da decisão2023-12-15

Código do produtoLYR

Comité consultivoMI

DecisãoSubstantially Equivalent

Resumo do dispositivo

Hp Detect™ Stool Antigen ELISA is the device name listed in this FDA 510(k) record. The listed applicant is Biomerica, Inc.. It received FDA 510(k) clearance on 2023-12-15 under 510(k) number K232892. 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 Hp Detect™ Stool Antigen ELISA?

Hp Detect™ Stool Antigen ELISA is a medical device that received FDA 510(k) clearance on 2023-12-15. The listed applicant is Biomerica, Inc.. The 510(k) number is K232892.

When did Hp Detect™ Stool Antigen ELISA receive FDA 510(k) clearance?

Hp Detect™ Stool Antigen ELISA received FDA 510(k) clearance on 2023-12-15, under 510(k) number K232892.

Who is the listed applicant for Hp Detect™ Stool Antigen ELISA?

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

What is the FDA product code for Hp Detect™ Stool Antigen ELISA?

The FDA product code for Hp Detect™ Stool Antigen ELISA is LYR.

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