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FDA 510(k)

Synthgene Home Test HCG Test Strip; Synthgene Home Test HCG Test Cassette; Synthgene Home Test HCG Test Midstream

N.º K: K242135 · 2025-01-31

SolicitanteNanjing Synthgene Medical Technology Co., Ltd.
Fecha de decisión2025-01-31
Código de productoLCX
Comité asesorCH
DecisiónSubstantially Equivalent

Resumen del dispositivo

Synthgene Home Test HCG Test Strip; Synthgene Home Test HCG Test Cassette; Synthgene Home Test HCG Test Midstream is the device name listed in this FDA 510(k) record. The listed applicant is Nanjing Synthgene Medical Technology Co., Ltd.. It received FDA 510(k) clearance on 2025-01-31 under 510(k) number K242135. 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 Synthgene Home Test HCG Test Strip; Synthgene Home Test HCG Test Cassette; Synthgene Home Test HCG Test Midstream?

Synthgene Home Test HCG Test Strip; Synthgene Home Test HCG Test Cassette; Synthgene Home Test HCG Test Midstream is a medical device that received FDA 510(k) clearance on 2025-01-31. The listed applicant is Nanjing Synthgene Medical Technology Co., Ltd.. The 510(k) number is K242135.

When did Synthgene Home Test HCG Test Strip; Synthgene Home Test HCG Test Cassette; Synthgene Home Test HCG Test Midstream receive FDA 510(k) clearance?

Synthgene Home Test HCG Test Strip; Synthgene Home Test HCG Test Cassette; Synthgene Home Test HCG Test Midstream received FDA 510(k) clearance on 2025-01-31, under 510(k) number K242135.

Who is the listed applicant for Synthgene Home Test HCG Test Strip; Synthgene Home Test HCG Test Cassette; Synthgene Home Test HCG Test Midstream?

The FDA 510(k) record lists Nanjing Synthgene Medical Technology Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Synthgene Home Test HCG Test Strip; Synthgene Home Test HCG Test Cassette; Synthgene Home Test HCG Test Midstream?

The FDA product code for Synthgene Home Test HCG Test Strip; Synthgene Home Test HCG Test Cassette; Synthgene Home Test HCG Test Midstream is LCX.

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Dispositivos relacionados (Código: LCX)

Los registros relacionados se emparejan automáticamente mediante nombres, códigos de producto u otros metadatos. Un emparejamiento no establece una relación clínica, científica, corporativa o regulatoria verificada; revise las fuentes oficiales enlazadas.

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Fuente oficial

Ver en la base de datos de la FDA →

Datos procedentes de la API abierta de la FDA. Para obtener la información más actualizada y autoritativa, consulte siempre el registro oficial.

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