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

    FISHER DIAG. PREGNACLONE TUBE PREGNANCY TEST KIT

    K Number: K844347 · Decision Jan 23, 1985
    View on FDA
    Classifications
    1
    FEI Numbers
    2
    Registration Numbers
    2
    Same Product Code
    95
    Applicant Total
    16
    Review Days
    75

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    Basic Information

    Device Name
    FISHER DIAG. PREGNACLONE TUBE PREGNANCY TEST KIT
    K Number
    K844347
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    862.1155
    Medical Specialty
    Clinical Chemistry
    Decision
    Substantially Equivalent
    Applicant
    Fisher Diagnostics
    Date Received
    November 9, 1984
    Decision Date
    January 23, 1985
    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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