BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇨🇳 China

    Innovita HCG Pregnancy Rapid Combo Test

    K Number: K241919 · Decision Aug 2, 2024
    View on FDA
    Classifications
    1
    FEI Numbers
    102
    Registration Numbers
    102
    Same Product Code
    374
    Applicant Total
    3
    Review Days
    32

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    Basic Information

    Device Name
    Innovita HCG Pregnancy Rapid Combo Test
    K Number
    K241919
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    862.1155
    Medical Specialty
    Clinical Chemistry
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Innovita (Tangshan) Biological Technology Co., Ltd.
    Date Received
    July 1, 2024
    Decision Date
    August 2, 2024
    Product Code
    JHI
    Advisory Committee
    Clinical Chemistry
    Review Advisory Committee
    CH
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    JHI Visual, Pregnancy Hcg, Prescription Use

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    Other Clearances by Innovita (Tangshan) Biological Technology Co., Ltd.

    K Number Device Name
    K250398 Innovita Flu A/B Antigen Rapid Test
    K192843 INNOVITA HCG Pregnancy Rapid Test Strip, INNOVITA HCG Pregnancy Rapid Test Cassette, INNOVITA HCG Pregnancy Rapid Test Midstream