FDA 510(k)

VeriClear Digital Early Result Pregnancy Test

Número K: K182328 · 2019-05-15

Data da decisão2019-05-15

Código do produtoLCX

Comité consultivoCH

DecisãoSubstantially Equivalent

Resumo do dispositivo

VeriClear Digital Early Result Pregnancy Test is the device name listed in this FDA 510(k) record. The listed applicant is True Diagnostics, Inc.. It received FDA 510(k) clearance on 2019-05-15 under 510(k) number K182328. 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 VeriClear Digital Early Result Pregnancy Test?

VeriClear Digital Early Result Pregnancy Test is a medical device that received FDA 510(k) clearance on 2019-05-15. The listed applicant is True Diagnostics, Inc.. The 510(k) number is K182328.

When did VeriClear Digital Early Result Pregnancy Test receive FDA 510(k) clearance?

VeriClear Digital Early Result Pregnancy Test received FDA 510(k) clearance on 2019-05-15, under 510(k) number K182328.

Who is the listed applicant for VeriClear Digital Early Result Pregnancy Test?

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

What is the FDA product code for VeriClear Digital Early Result Pregnancy Test?

The FDA product code for VeriClear Digital Early Result Pregnancy Test is LCX.

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Outros registros que listam True Diagnostics, Inc. como candidato(a)

K172257TrueDX hCG Early Result Pregnancy Test (Midstream Format), TrueDX hCG Early Result Pregnancy Test (Cassette Format), VeriClear Early Result Pregnancy Test (Midstream Format), VeriClear Early Result Pregnancy Test (Cassette Format)

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.

Fonte oficial

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