FDA 510(k)

Cassete de Prueba Rápida de Embarazo HIGHTOP, Cinta de Prueba Rápida de Embarazo HIGHTOP, Prueba Rápida de Embarazo Midstream HIGHTOP

N.º K: K192123 · 2019-09-05

SolicitanteQingdao Hightop Biotech Co., Ltd.

Fecha de decisión2019-09-05

Código de productoLCX

Comité asesorCH

DecisiónSubstantially Equivalent

Resumen del dispositivo

HIGHTOP Pregnancy Rapid Test Cassette, HIGHTOP Pregnancy Rapid Test Strip, HIGHTOP Pregnancy Rapid Test Midstream is the device name listed in this FDA 510(k) record. The listed applicant is Qingdao Hightop Biotech Co., Ltd.. It received FDA 510(k) clearance on 2019-09-05 under 510(k) number K192123. 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 HIGHTOP Pregnancy Rapid Test Cassette, HIGHTOP Pregnancy Rapid Test Strip, HIGHTOP Pregnancy Rapid Test Midstream?

HIGHTOP Pregnancy Rapid Test Cassette, HIGHTOP Pregnancy Rapid Test Strip, HIGHTOP Pregnancy Rapid Test Midstream is a medical device that received FDA 510(k) clearance on 2019-09-05. The listed applicant is Qingdao Hightop Biotech Co., Ltd.. The 510(k) number is K192123.

When did HIGHTOP Pregnancy Rapid Test Cassette, HIGHTOP Pregnancy Rapid Test Strip, HIGHTOP Pregnancy Rapid Test Midstream receive FDA 510(k) clearance?

HIGHTOP Pregnancy Rapid Test Cassette, HIGHTOP Pregnancy Rapid Test Strip, HIGHTOP Pregnancy Rapid Test Midstream received FDA 510(k) clearance on 2019-09-05, under 510(k) number K192123.

Who is the listed applicant for HIGHTOP Pregnancy Rapid Test Cassette, HIGHTOP Pregnancy Rapid Test Strip, HIGHTOP Pregnancy Rapid Test Midstream?

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

What is the FDA product code for HIGHTOP Pregnancy Rapid Test Cassette, HIGHTOP Pregnancy Rapid Test Strip, HIGHTOP Pregnancy Rapid Test Midstream?

The FDA product code for HIGHTOP Pregnancy Rapid Test Cassette, HIGHTOP Pregnancy Rapid Test Strip, HIGHTOP Pregnancy Rapid Test Midstream is LCX.

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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.

Fuente oficial

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