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

    DIAGNON B12 57CO RIA KIT

    K Number: K832717 · Decision Dec 8, 1983
    View on FDA
    Classifications
    1
    FEI Numbers
    31
    Registration Numbers
    31
    Same Product Code
    77
    Applicant Total
    6
    Review Days
    118

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    Basic Information

    Device Name
    DIAGNON B12 57CO RIA KIT
    K Number
    K832717
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    862.1810
    Medical Specialty
    Clinical Chemistry
    Decision
    Substantially Equivalent
    Applicant
    Diagnon Corp.
    Date Received
    August 12, 1983
    Decision Date
    December 8, 1983
    Product Code
    CDD
    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
    CDD Radioassay, Vitamin B12

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