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

    SWEAT CONTROLS FOR CYSTIC FIBROSIS TESTING

    K Number: K943925 · Decision Oct 4, 1994
    View on FDA
    Classifications
    1
    FEI Numbers
    10
    Registration Numbers
    10
    Same Product Code
    16
    Applicant Total
    38
    Review Days
    53

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    Basic Information

    Device Name
    SWEAT CONTROLS FOR CYSTIC FIBROSIS TESTING
    K Number
    K943925
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    862.1660
    Medical Specialty
    Clinical Chemistry
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Quantimetrix Corp.
    Date Received
    August 12, 1994
    Decision Date
    October 4, 1994
    Product Code
    JJR
    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
    JJR Electrolyte Controls (Assayed And Unassayed)

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