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

    MODIFICATION TO ALPHA DX SYSTEM

    K Number: K013118 · Decision Oct 15, 2001
    View on FDA
    Classifications
    1
    FEI Numbers
    34
    Registration Numbers
    34
    Same Product Code
    47
    Applicant Total
    4
    Review Days
    27

    Basic Information

    Device Name
    MODIFICATION TO ALPHA DX SYSTEM
    K Number
    K013118
    Device Class
    FDA class 2
    Clearance Type
    Special
    Regulation Number
    862.1215
    Medical Specialty
    Clinical Chemistry
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    FIRST MEDICAL, INC.
    Date Received
    September 18, 2001
    Decision Date
    October 15, 2001
    Product Code
    JHX
    Advisory Committee
    Clinical Chemistry
    Review Advisory Committee
    CH
    Third Party
    N

    Classifications

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

    Product Code Device Name
    JHX Fluorometric Method, Cpk Or Isoenzymes

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    Other Clearances by FIRST MEDICAL, INC.

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    K014024 MODIFICATION TO ALPHA DX SYSTEM
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