BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇬🇧 United Kingdom

    QACA IGG/IGM ELISA KIT HRP

    K Number: K021192 · Decision May 16, 2002
    View on FDA
    Classifications
    1
    FEI Numbers
    25
    Registration Numbers
    25
    Same Product Code
    93
    Applicant Total
    6
    Review Days
    31

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    Basic Information

    Device Name
    QACA IGG/IGM ELISA KIT HRP
    K Number
    K021192
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    866.5660
    Medical Specialty
    Immunology
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Cheshire Diagnostics , Ltd.
    Date Received
    April 15, 2002
    Decision Date
    May 16, 2002
    Product Code
    MID
    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
    MID System, Test, Anticardiolipin Immunological

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    Other Clearances by Cheshire Diagnostics , Ltd.

    K Number Device Name
    K021611 QAB2A IGG ELISA KIT HRP
    K021610 QAB2A IGM ELISA KIT HRP
    K020695 QAB2A IGG ELISA KIT
    K020694 QAB2A IGM ELISA KIT
    K020241 QACA IGG/IGM ELISA KIT