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

    ALPHA DX SYSTEM

    K Number: K010562 · Decision Mar 13, 2001
    View on FDA
    Classifications
    1
    FEI Numbers
    50
    Registration Numbers
    50
    Same Product Code
    94
    Applicant Total
    4
    Review Days
    15

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    Basic Information

    Device Name
    ALPHA DX SYSTEM
    K Number
    K010562
    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
    February 26, 2001
    Decision Date
    March 13, 2001
    Product Code
    MMI
    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
    MMI Immunoassay Method, Troponin Subunit

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    Other Clearances by First Medical, Inc.

    K Number Device Name
    K014024 MODIFICATION TO ALPHA DX SYSTEM
    K013118 MODIFICATION TO ALPHA DX SYSTEM
    K974839 ALPHA DX ANALYZER 01-0100, ALPHA DX MYO/CK/CK-MB/TNI CARDIAC PANEL TEST KIT 03-0001, ALPHA DX CK/CK-MB PANEL TEST KIT