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

    PREGNACOL PREGNANCY TEST

    K Number: K972606 · Decision Aug 29, 1997
    View on FDA
    Classifications
    1
    FEI Numbers
    2
    Registration Numbers
    2
    Same Product Code
    95
    Applicant Total
    14
    Review Days
    49

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    Basic Information

    Device Name
    PREGNACOL PREGNANCY TEST
    K Number
    K972606
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    862.1155
    Medical Specialty
    Clinical Chemistry
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Immunostics Inc.,
    Date Received
    July 11, 1997
    Decision Date
    August 29, 1997
    Product Code
    JHJ
    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
    JHJ Agglutination Method, Human Chorionic Gonadotropin

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