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

    ACETYLCHOLINE RECEPTOR AB (ARAB)RRA

    K Number: K051144 · Decision Nov 18, 2005
    View on FDA
    Classifications
    1
    FEI Numbers
    4
    Registration Numbers
    4
    Same Product Code
    3
    Applicant Total
    2
    Review Days
    198

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    Basic Information

    Device Name
    ACETYLCHOLINE RECEPTOR AB (ARAB)RRA
    K Number
    K051144
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    866.5660
    Medical Specialty
    Immunology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Ibl-Hamburg GmbH
    Date Received
    May 4, 2005
    Decision Date
    November 18, 2005
    Product Code
    NST
    Advisory Committee
    Immunology
    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
    NST Autoantibodies, Acetylcholine Receptor, Acetylcholine Blocking And Non-Blocking

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    Other Clearances by Ibl-Hamburg GmbH

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