FDA 510(k)

Teste de Gravidez Early Pregnancy Test ACESO

Número K: K234152 · 2024-04-05

Data da decisão2024-04-05

Código do produtoLCX

Comité consultivoCH

DecisãoSubstantially Equivalent

Resumo do dispositivo

ACESO Early Pregnancy Test is the device name listed in this FDA 510(k) record. The listed applicant is Aceso Laboratories, Inc.. It received FDA 510(k) clearance on 2024-04-05 under 510(k) number K234152. The device is classified under product code LCX. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the ACESO Early Pregnancy Test?

ACESO Early Pregnancy Test is a medical device that received FDA 510(k) clearance on 2024-04-05. The listed applicant is Aceso Laboratories, Inc.. The 510(k) number is K234152.

When did ACESO Early Pregnancy Test receive FDA 510(k) clearance?

ACESO Early Pregnancy Test received FDA 510(k) clearance on 2024-04-05, under 510(k) number K234152.

Who is the listed applicant for ACESO Early Pregnancy Test?

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

What is the FDA product code for ACESO Early Pregnancy Test?

The FDA product code for ACESO Early Pregnancy Test is LCX.

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