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

    SLIDE TEST FOR PREGNANCY, GRAVINDEX 90

    K Number: K782166 · Decision Apr 4, 1979
    View on FDA
    Classifications
    1
    FEI Numbers
    2
    Registration Numbers
    2
    Same Product Code
    95
    Applicant Total
    24
    Review Days
    96

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    Basic Information

    Device Name
    SLIDE TEST FOR PREGNANCY, GRAVINDEX 90
    K Number
    K782166
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    862.1155
    Medical Specialty
    Clinical Chemistry
    Decision
    Substantially Equivalent
    Applicant
    Ortho Diagnostics, Inc.
    Date Received
    December 29, 1978
    Decision Date
    April 4, 1979
    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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