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

    DYNABEADS HLA CELL PREP II ISOLATION PRODUCT

    K Number: K873185 · Decision Nov 4, 1987
    View on FDA
    Classifications
    1
    FEI Numbers
    15
    Registration Numbers
    15
    Same Product Code
    11
    Applicant Total
    1
    Review Days
    84

    Basic Information

    Device Name
    DYNABEADS HLA CELL PREP II ISOLATION PRODUCT
    K Number
    K873185
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    864.8500
    Medical Specialty
    Hematology
    Decision
    Substantially Equivalent
    Applicant
    DYNAL BIOTECH, INC.
    Date Received
    August 12, 1987
    Decision Date
    November 4, 1987
    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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