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

    ACA(R) BETA-2-MICROGLOBULIN (B2M) TEST PACK

    K Number: K914226 · Decision Nov 19, 1991
    View on FDA
    Classifications
    1
    FEI Numbers
    88
    Registration Numbers
    88
    Same Product Code
    3
    Applicant Total
    253
    Review Days
    60

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    Basic Information

    Device Name
    ACA(R) BETA-2-MICROGLOBULIN (B2M) TEST PACK
    K Number
    K914226
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    874.4420
    Medical Specialty
    Ear, Nose, Throat
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    E.I. Dupont DE Nemours & Co., Inc.
    Date Received
    September 20, 1991
    Decision Date
    November 19, 1991
    Product Code
    JZB
    Advisory Committee
    Ear, Nose, Throat
    Review Advisory Committee
    IM
    Third Party
    N

    Classifications

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

    Product Code Device Name
    JZB Scissors, Ear

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