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

    ALPHA PLASMA TRANSFER SET

    K Number: K820447 · Decision Apr 14, 1982
    View on FDA
    Classifications
    1
    FEI Numbers
    21
    Registration Numbers
    21
    Same Product Code
    5
    Applicant Total
    8
    Review Days
    55

    Basic Information

    Device Name
    ALPHA PLASMA TRANSFER SET
    K Number
    K820447
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    864.9875
    Medical Specialty
    Hematology
    Decision
    Substantially Equivalent
    Applicant
    ALPHA THERAPEUTIC CORP.
    Date Received
    February 18, 1982
    Decision Date
    April 14, 1982
    Product Code
    KSB
    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
    KSB Set, Transfer (Blood/Plasma)

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