FDA 510(k)

Preview Digital Pregnancy Test

N.º K: K173229 · 2018-03-12

SolicitanteGuangzhou Wondfo Biotech Co., Ltd.

Fecha de decisión2018-03-12

Código de productoLCX

Comité asesorCH

DecisiónSubstantially Equivalent

Resumen del dispositivo

Preview Digital Pregnancy Test is the device name listed in this FDA 510(k) record. The listed applicant is Guangzhou Wondfo Biotech Co., Ltd.. It received FDA 510(k) clearance on 2018-03-12 under 510(k) number K173229. The device is classified under product code LCX. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Preguntas frecuentes

What is the Preview Digital Pregnancy Test?

Preview Digital Pregnancy Test is a medical device that received FDA 510(k) clearance on 2018-03-12. The listed applicant is Guangzhou Wondfo Biotech Co., Ltd.. The 510(k) number is K173229.

When did Preview Digital Pregnancy Test receive FDA 510(k) clearance?

Preview Digital Pregnancy Test received FDA 510(k) clearance on 2018-03-12, under 510(k) number K173229.

Who is the listed applicant for Preview Digital Pregnancy Test?

The FDA 510(k) record lists Guangzhou Wondfo Biotech Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Preview Digital Pregnancy Test?

The FDA product code for Preview Digital Pregnancy Test is LCX.

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Otros registros que enlistan a Guangzhou Wondfo Biotech Co., Ltd. como solicitante

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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.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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