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

    LIQUISPEX(TM) LIQUID B2M CONTROL LEVEL 1 AND 2

    K Number: K946048 · Decision Feb 10, 1995
    View on FDA
    Classifications
    1
    FEI Numbers
    34
    Registration Numbers
    34
    Same Product Code
    52
    Applicant Total
    17
    Review Days
    60

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    Basic Information

    Device Name
    LIQUISPEX(TM) LIQUID B2M CONTROL LEVEL 1 AND 2
    K Number
    K946048
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    866.5630
    Medical Specialty
    Immunology
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Clinical Controls, Inc.
    Date Received
    December 12, 1994
    Decision Date
    February 10, 1995
    Product Code
    JZG
    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
    JZG System, Test, Beta-2-Microglobulin Immunological

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