FDA 510(k)

Copo de Teste de Drogas Xenta, Cartão de Teste de Drogas Xenta

Número K: K231137 · 2023-05-19

RequerenteXenta Biomedical Science Co., Ltd.

Data da decisão2023-05-19

Código do produtoDKZ

Comité consultivoTX

DecisãoSubstantially Equivalent

Resumo do dispositivo

Xenta Drug Screen Cup, Xenta Drug Screen Dipcard is the device name listed in this FDA 510(k) record. The listed applicant is Xenta Biomedical Science Co., Ltd.. It received FDA 510(k) clearance on 2023-05-19 under 510(k) number K231137. The device is classified under product code DKZ. It was reviewed by the TX advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the Xenta Drug Screen Cup, Xenta Drug Screen Dipcard?

Xenta Drug Screen Cup, Xenta Drug Screen Dipcard is a medical device that received FDA 510(k) clearance on 2023-05-19. The listed applicant is Xenta Biomedical Science Co., Ltd.. The 510(k) number is K231137.

When did Xenta Drug Screen Cup, Xenta Drug Screen Dipcard receive FDA 510(k) clearance?

Xenta Drug Screen Cup, Xenta Drug Screen Dipcard received FDA 510(k) clearance on 2023-05-19, under 510(k) number K231137.

Who is the listed applicant for Xenta Drug Screen Cup, Xenta Drug Screen Dipcard?

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

What is the FDA product code for Xenta Drug Screen Cup, Xenta Drug Screen Dipcard?

The FDA product code for Xenta Drug Screen Cup, Xenta Drug Screen Dipcard is DKZ.

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Outros registros que listam Xenta Biomedical Science Co., Ltd. como candidato(a)

K222955Copo de Teste de Drogas Xenta, Cartão de Teste de Drogas Xenta

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