FDA 510(k)

Innovita HCG Pregnancy Rapid Combo Test

N.º K: K241919 · 2024-08-02

SolicitanteInnovita (Tangshan) Biological Technology Co., Ltd.

Fecha de decisión2024-08-02

Código de productoJHI

Comité asesorCH

DecisiónSubstantially Equivalent

Resumen del dispositivo

Innovita HCG Pregnancy Rapid Combo Test is the device name listed in this FDA 510(k) record. The listed applicant is Innovita (Tangshan) Biological Technology Co., Ltd.. It received FDA 510(k) clearance on 2024-08-02 under 510(k) number K241919. The device is classified under product code JHI. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Preguntas frecuentes

What is the Innovita HCG Pregnancy Rapid Combo Test?

Innovita HCG Pregnancy Rapid Combo Test is a medical device that received FDA 510(k) clearance on 2024-08-02. The listed applicant is Innovita (Tangshan) Biological Technology Co., Ltd.. The 510(k) number is K241919.

When did Innovita HCG Pregnancy Rapid Combo Test receive FDA 510(k) clearance?

Innovita HCG Pregnancy Rapid Combo Test received FDA 510(k) clearance on 2024-08-02, under 510(k) number K241919.

Who is the listed applicant for Innovita HCG Pregnancy Rapid Combo Test?

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

What is the FDA product code for Innovita HCG Pregnancy Rapid Combo Test?

The FDA product code for Innovita HCG Pregnancy Rapid Combo Test is JHI.

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Otros registros que enlistan a Innovita (Tangshan) Biological Technology Co., Ltd. como solicitante

K250398Innovita Flu A/B Antigen Rapid Test K192843INNOVITA HCG Pregnancy Rapid Test Strip, INNOVITA HCG Pregnancy Rapid Test Cassette, INNOVITA HCG Pregnancy Rapid Test Midstream

Dispositivos relacionados (Código: JHI)

K262299Instant-View® hCG Combo II Cassette TestAlfa Scientific Designs, Inc.K203272Cassete de Prueba Rápida de Embarazo AlltestHangzhou AllTest Biotech Co., Ltd.K172322Atellica IM Total hCG (ThCG)Siemens Healthcare Diagnostics, Inc.K172257TrueDX hCG Early Result Pregnancy Test (Midstream Format), TrueDX hCG Early Result Pregnancy Test (Cassette Format), VeriClear Early Result Pregnancy Test (Midstream Format), VeriClear Early Result Pregnancy Test (Cassette Format)True Diagnostics, Inc.K152768Assure Tech hCG Pregnancy Serum/Urine Combo Test Cassette, Assure Tech hCG Pregnancy Serum/Urine Combo Test StripAssure Tech. Co., Ltd.

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.