FDA 510(k)

FaStep Pregnancy Rapid Test Cassette; Fastep HCG Rapid Test Cassette

Número K: K250117 · 2025-02-13

Data da decisão2025-02-13

Código do produtoLCX

Comité consultivoCH

DecisãoSubstantially Equivalent

Resumo do dispositivo

FaStep Pregnancy Rapid Test Cassette; Fastep HCG Rapid Test Cassette is the device name listed in this FDA 510(k) record. The listed applicant is Assure Tech., LLC. It received FDA 510(k) clearance on 2025-02-13 under 510(k) number K250117. 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 FaStep Pregnancy Rapid Test Cassette; Fastep HCG Rapid Test Cassette?

FaStep Pregnancy Rapid Test Cassette; Fastep HCG Rapid Test Cassette is a medical device that received FDA 510(k) clearance on 2025-02-13. The listed applicant is Assure Tech., LLC. The 510(k) number is K250117.

When did FaStep Pregnancy Rapid Test Cassette; Fastep HCG Rapid Test Cassette receive FDA 510(k) clearance?

FaStep Pregnancy Rapid Test Cassette; Fastep HCG Rapid Test Cassette received FDA 510(k) clearance on 2025-02-13, under 510(k) number K250117.

Who is the listed applicant for FaStep Pregnancy Rapid Test Cassette; Fastep HCG Rapid Test Cassette?

The FDA 510(k) record lists Assure Tech., LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for FaStep Pregnancy Rapid Test Cassette; Fastep HCG Rapid Test Cassette?

The FDA product code for FaStep Pregnancy Rapid Test Cassette; Fastep HCG Rapid Test Cassette is LCX.

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Outros registros que listam Assure Tech., LLC como candidato(a)

K261984AssureTech Quick Cup Tests;AssureTech Multi-drug Urine Test Cup K260754Fastep COVID-19 Antigen Pen Home Test; Fastep COVID-19 Antigen Pen Test K252259AssureTech Quick Cup Tests; AssureTech Multi-drug Urine Test Cup K243996AssureTech Panel Dip Tests; AssureTech Quick Cup Tests; AssureTech Multi-drug Urine Test Panel; AssureTech Multi-drug Urine Test Cup K243573FaStep Early Pregnancy Rapid Test Strip; FaStep Early Pregnancy Rapid Test Cassette; FaStep Early Pregnancy Rapid Test Midstream K240351FaStep Fentanyl Rapid Test Device (Urine); FaStep Rapid Fentanyl Urine Test (Urine)

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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.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.K240242HCG Home Use Pregnancy Test Strip (Colloidal Gold), HCG Home Use Pregnancy Test Cassette (Colloidal Gold), HCG Home Use Pregnancy Test Midstream (Colloidal Gold)Anhui Deepblue Medical Technology Co., Ltd.

Fonte oficial

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