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

    DELFIA(TM) HIGE KIT

    K Number: K871599 · Decision Jun 12, 1987
    View on FDA
    Classifications
    1
    FEI Numbers
    21
    Registration Numbers
    21
    Same Product Code
    261
    Applicant Total
    52
    Review Days
    49

    Basic Information

    Device Name
    DELFIA(TM) HIGE KIT
    K Number
    K871599
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    866.5750
    Medical Specialty
    Immunology
    Decision
    Substantially Equivalent
    Applicant
    LKB INSTRUMENTS, INC.
    Date Received
    April 24, 1987
    Decision Date
    June 12, 1987
    Product Code
    DHB
    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
    DHB System, Test, Radioallergosorbent (Rast) Immunological

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