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

    RETIC SET

    K Number: K821318 · Decision Jun 2, 1982
    View on FDA
    Classifications
    1
    FEI Numbers
    5
    Registration Numbers
    5
    Same Product Code
    0
    Applicant Total
    79
    Review Days
    29

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    Basic Information

    Device Name
    RETIC SET
    K Number
    K821318
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    864.1850
    Medical Specialty
    Hematology
    Decision
    Substantially Equivalent
    Applicant
    R&D Systems, Inc.
    Date Received
    May 4, 1982
    Decision Date
    June 2, 1982
    Product Code
    KJN
    Advisory Committee
    Hematology
    Review Advisory Committee
    HE
    Third Party
    N

    Classifications

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

    Product Code Device Name
    KJN Brilliant Cresyl Blue

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