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

    LYMPHO SEP(TM)

    K Number: K902445 · Decision Aug 22, 1990
    View on FDA
    Classifications
    1
    FEI Numbers
    13
    Registration Numbers
    13
    Same Product Code
    11
    Applicant Total
    11
    Review Days
    82

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    Basic Information

    Device Name
    LYMPHO SEP(TM)
    K Number
    K902445
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    864.8500
    Medical Specialty
    Hematology
    Decision
    Substantially Equivalent
    Applicant
    Icn Biomedicals, Inc.
    Date Received
    June 1, 1990
    Decision Date
    August 22, 1990
    Product Code
    JCF
    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
    JCF Lymphocyte Separation Medium

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