FDA 510(k)

Teste Rápido de Gravidade ACRO HCG

Número K: K172512 · 2018-02-02

Data da decisão2018-02-02

Código do produtoLCX

Comité consultivoCH

DecisãoSubstantially Equivalent

Resumo do dispositivo

ACRO HCG Pregnancy Rapid Test is the device name listed in this FDA 510(k) record. The listed applicant is Acro Biotech, Inc.. It received FDA 510(k) clearance on 2018-02-02 under 510(k) number K172512. 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 ACRO HCG Pregnancy Rapid Test?

ACRO HCG Pregnancy Rapid Test is a medical device that received FDA 510(k) clearance on 2018-02-02. The listed applicant is Acro Biotech, Inc.. The 510(k) number is K172512.

When did ACRO HCG Pregnancy Rapid Test receive FDA 510(k) clearance?

ACRO HCG Pregnancy Rapid Test received FDA 510(k) clearance on 2018-02-02, under 510(k) number K172512.

Who is the listed applicant for ACRO HCG Pregnancy Rapid Test?

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

What is the FDA product code for ACRO HCG Pregnancy Rapid Test?

The FDA product code for ACRO HCG Pregnancy Rapid Test is LCX.

Ensaios clínicos relacionados

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Outros registros que listam Acro Biotech, Inc. como candidato(a)

K180771Teste Rápido de Gravidade Acro HCG

Dispositivos Relacionados (Código: LCX)

K251040MissLan® Early Detection Digital Pregnancy Test; MissLan® Early Result Digital Pregnancy TestGuangzhou Decheng Biotechnology Co., Ltd.K251053Shinetell PlusTM Digital Early Pregnancy TestHangzhou AllTest Biotech Co., Ltd.K250117FaStep Pregnancy Rapid Test Cassette; Fastep HCG Rapid Test CassetteAssure Tech., LLC K242135Synthgene Home Test HCG Test Strip; Synthgene Home Test HCG Test Cassette; Synthgene Home Test HCG Test MidstreamNanjing Synthgene Medical Technology Co., Ltd.K243573FaStep Early Pregnancy Rapid Test Strip; FaStep Early Pregnancy Rapid Test Cassette; FaStep Early Pregnancy Rapid Test MidstreamAssure Tech., LLC K241394iHealth® Early Pregnancy Test; iHealth® Early Pregnancy Test StripAndon Health Co, Ltd.

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