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

    MODEL 644 SWEAT DILUENT

    K Number: K935228 · Decision Aug 1, 1994
    View on FDA
    Classifications
    1
    FEI Numbers
    77
    Registration Numbers
    77
    Same Product Code
    37
    Applicant Total
    125
    Review Days
    273

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    Basic Information

    Device Name
    MODEL 644 SWEAT DILUENT
    K Number
    K935228
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    862.1170
    Medical Specialty
    Clinical Chemistry
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Ciba Corning Diagnostics Corp.
    Date Received
    November 1, 1993
    Decision Date
    August 1, 1994
    Product Code
    CGZ
    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
    CGZ Electrode, Ion-Specific, Chloride

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