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

    PHOENIX ISE STANDARD A,B AND C FOR ROCHE/AVL SYSTEMS

    K Number: K023268 · Decision Nov 15, 2002
    View on FDA
    Classifications
    1
    FEI Numbers
    101
    Registration Numbers
    101
    Same Product Code
    301
    Applicant Total
    21
    Review Days
    46

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    Basic Information

    Device Name
    PHOENIX ISE STANDARD A,B AND C FOR ROCHE/AVL SYSTEMS
    K Number
    K023268
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    862.1150
    Medical Specialty
    Clinical Chemistry
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Phoenix Diagnostics, Inc.
    Date Received
    September 30, 2002
    Decision Date
    November 15, 2002
    Product Code
    JIX
    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
    JIX Calibrator, Multi-Analyte Mixture

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    K013451 PHOENOIX ISE REAGENTS FOR ROCHE HITACHI, MODELS 700/900 SERIES
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    K960592 ELECTROLYTE STANDARDS
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