FDA 510(k)

EasyScreen Gastrointestinal Parasite Detection Kit

Número K: K232672 · 2024-05-29

Data da decisão2024-05-29

Código do produtoPCH

Comité consultivoMI

DecisãoSubstantially Equivalent

Resumo do dispositivo

EasyScreen Gastrointestinal Parasite Detection Kit is the device name listed in this FDA 510(k) record. The listed applicant is Genetic Signatures Limited. It received FDA 510(k) clearance on 2024-05-29 under 510(k) number K232672. 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 EasyScreen Gastrointestinal Parasite Detection Kit?

EasyScreen Gastrointestinal Parasite Detection Kit is a medical device that received FDA 510(k) clearance on 2024-05-29. The listed applicant is Genetic Signatures Limited. The 510(k) number is K232672.

When did EasyScreen Gastrointestinal Parasite Detection Kit receive FDA 510(k) clearance?

EasyScreen Gastrointestinal Parasite Detection Kit received FDA 510(k) clearance on 2024-05-29, under 510(k) number K232672.

Who is the listed applicant for EasyScreen Gastrointestinal Parasite Detection Kit?

The FDA 510(k) record lists Genetic Signatures Limited as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for EasyScreen Gastrointestinal Parasite Detection Kit?

The FDA product code for EasyScreen Gastrointestinal Parasite Detection Kit is PCH.

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