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FDA 510(k)

EGENS Pregnancy Test Midstream I, EGENS Pregnancy Test Midstream II

N.º K: K232864 · 2024-01-26

SolicitanteNantong Egens Biotechnology Co., Ltd.
Fecha de decisión2024-01-26
Código de productoLCX
Comité asesorCH
DecisiónSubstantially Equivalent

Resumen del dispositivo

EGENS Pregnancy Test Midstream I, EGENS Pregnancy Test Midstream II is the device name listed in this FDA 510(k) record. The listed applicant is Nantong Egens Biotechnology Co., Ltd.. It received FDA 510(k) clearance on 2024-01-26 under 510(k) number K232864. 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 EGENS Pregnancy Test Midstream I, EGENS Pregnancy Test Midstream II?

EGENS Pregnancy Test Midstream I, EGENS Pregnancy Test Midstream II is a medical device that received FDA 510(k) clearance on 2024-01-26. The listed applicant is Nantong Egens Biotechnology Co., Ltd.. The 510(k) number is K232864.

When did EGENS Pregnancy Test Midstream I, EGENS Pregnancy Test Midstream II receive FDA 510(k) clearance?

EGENS Pregnancy Test Midstream I, EGENS Pregnancy Test Midstream II received FDA 510(k) clearance on 2024-01-26, under 510(k) number K232864.

Who is the listed applicant for EGENS Pregnancy Test Midstream I, EGENS Pregnancy Test Midstream II?

The FDA 510(k) record lists Nantong Egens Biotechnology Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for EGENS Pregnancy Test Midstream I, EGENS Pregnancy Test Midstream II?

The FDA product code for EGENS Pregnancy Test Midstream I, EGENS Pregnancy Test Midstream II 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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