BEUDAMED
    FDA 510(k) FDA class 1 Substantially Equivalent 🇺🇸 United States

    IRON TEST

    K Number: K935176 · Decision Dec 16, 1993
    View on FDA
    Classifications
    1
    FEI Numbers
    35
    Registration Numbers
    35
    Same Product Code
    66
    Applicant Total
    288
    Review Days
    50

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    Basic Information

    Device Name
    IRON TEST
    K Number
    K935176
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    862.1410
    Medical Specialty
    Clinical Chemistry
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Em Diagnostic Systems, Inc.
    Date Received
    October 27, 1993
    Decision Date
    December 16, 1993
    Product Code
    JIY
    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
    JIY Photometric Method, Iron (Non-Heme)

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