BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇺🇸 United States

    VICTORCH MEDITEK'S HCG TEST CARD

    K Number: K013678 · Decision Dec 27, 2001
    View on FDA
    Classifications
    1
    FEI Numbers
    42
    Registration Numbers
    42
    Same Product Code
    71
    Applicant Total
    2
    Review Days
    50

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    Basic Information

    Device Name
    VICTORCH MEDITEK'S HCG TEST CARD
    K Number
    K013678
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    862.1155
    Medical Specialty
    Clinical Chemistry
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Victorch Meditek, Inc.
    Date Received
    November 7, 2001
    Decision Date
    December 27, 2001
    Product Code
    DHA
    Advisory Committee
    Clinical Chemistry
    Review Advisory Committee
    CH
    Third Party
    Y

    Classifications

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

    Product Code Device Name
    DHA System, Test, Human Chorionic Gonadotropin

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    Other Clearances by Victorch Meditek, Inc.

    K Number Device Name
    K013702 VICTORCH HCG TEST STRIP