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    FDA 510(k) FDA class 1 Substantially Equivalent 🇮🇩 Indonesia

    SERUM AMMONIA CONTROL

    K Number: K935606 · Decision Mar 22, 1994
    View on FDA
    Classifications
    1
    FEI Numbers
    269
    Registration Numbers
    269
    Same Product Code
    492
    Applicant Total
    2
    Review Days
    123

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    Basic Information

    Device Name
    SERUM AMMONIA CONTROL
    K Number
    K935606
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    862.1660
    Medical Specialty
    Clinical Chemistry
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    P.T. Meditrol
    Date Received
    November 19, 1993
    Decision Date
    March 22, 1994
    Product Code
    JJX
    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
    JJX Single (Specified) Analyte Controls (Assayed And Unassayed)

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