BEUDAMED
    FDA 510(k) FDA class 1 Substantially Equivalent 🇺🇸 United States

    IMMULON 4 FLAT BOTTOM PLATES & REMOVAWELL STRIPS

    K Number: K881675 · Decision Apr 21, 1988
    View on FDA
    Classifications
    1
    FEI Numbers
    5
    Registration Numbers
    5
    Same Product Code
    6
    Applicant Total
    44
    Review Days
    3

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    Basic Information

    Device Name
    IMMULON 4 FLAT BOTTOM PLATES & REMOVAWELL STRIPS
    K Number
    K881675
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    866.4800
    Medical Specialty
    Immunology
    Decision
    Substantially Equivalent
    Applicant
    Dynatech Laboratories, Inc.
    Date Received
    April 18, 1988
    Decision Date
    April 21, 1988
    Product Code
    JZQ
    Advisory Committee
    Immunology
    Review Advisory Committee
    IM
    Third Party
    N

    Classifications

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

    Product Code Device Name
    JZQ Plates And Equipment, Radial Immunodiffusion

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