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FDA 510(k)

WHOLEPOWER Pregnancy Rapid Test Cassette, WHOLEPOWER Pregnancy Rapid Test Strip, WHOLEPOWER Pregnancy Rapid Test Midstream

N.º K: K190705 · 2019-04-15

SolicitanteWholepower Biotech Co., Ltd.
Fecha de decisión2019-04-15
Código de productoLCX
Comité asesorCH
DecisiónSubstantially Equivalent

Resumen del dispositivo

WHOLEPOWER Pregnancy Rapid Test Cassette, WHOLEPOWER Pregnancy Rapid Test Strip, WHOLEPOWER Pregnancy Rapid Test Midstream is the device name listed in this FDA 510(k) record. The listed applicant is Wholepower Biotech Co., Ltd.. It received FDA 510(k) clearance on 2019-04-15 under 510(k) number K190705. 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 WHOLEPOWER Pregnancy Rapid Test Cassette, WHOLEPOWER Pregnancy Rapid Test Strip, WHOLEPOWER Pregnancy Rapid Test Midstream?

WHOLEPOWER Pregnancy Rapid Test Cassette, WHOLEPOWER Pregnancy Rapid Test Strip, WHOLEPOWER Pregnancy Rapid Test Midstream is a medical device that received FDA 510(k) clearance on 2019-04-15. The listed applicant is Wholepower Biotech Co., Ltd.. The 510(k) number is K190705.

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

WHOLEPOWER Pregnancy Rapid Test Cassette, WHOLEPOWER Pregnancy Rapid Test Strip, WHOLEPOWER Pregnancy Rapid Test Midstream received FDA 510(k) clearance on 2019-04-15, under 510(k) number K190705.

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

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

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

The FDA product code for WHOLEPOWER Pregnancy Rapid Test Cassette, WHOLEPOWER Pregnancy Rapid Test Strip, WHOLEPOWER Pregnancy Rapid 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

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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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