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

    DIAGNON FOLATE 125I RIA KIT

    K Number: K841302 · Decision Jun 22, 1984
    View on FDA
    Classifications
    1
    FEI Numbers
    34
    Registration Numbers
    34
    Same Product Code
    63
    Applicant Total
    6
    Review Days
    84

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    Basic Information

    Device Name
    DIAGNON FOLATE 125I RIA KIT
    K Number
    K841302
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    862.1295
    Medical Specialty
    Clinical Chemistry
    Decision
    Substantially Equivalent
    Applicant
    Diagnon Corp.
    Date Received
    March 30, 1984
    Decision Date
    June 22, 1984
    Product Code
    CGN
    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
    CGN Acid, Folic, Radioimmunoassay

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