FDA 510(k)

Innovita HCG Pregnancy Rapid Combo Test

Número K: K241919 · 2024-08-02

RequerenteInnovita (Tangshan) Biological Technology Co., Ltd.

Data da decisão2024-08-02

Código do produtoJHI

Comité consultivoCH

DecisãoSubstantially Equivalent

Resumo do 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.

Perguntas frequentes

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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Outros registros que listam Innovita (Tangshan) Biological Technology Co., Ltd. como candidato(a)

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 Teste Rápido de Gravidez 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.

Fonte oficial

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