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

    STAT-TRAK LIQUID ELECTROLYTE CONTROL

    K Number: K831389 · Decision Aug 10, 1983
    View on FDA
    Classifications
    1
    FEI Numbers
    10
    Registration Numbers
    10
    Same Product Code
    16
    Applicant Total
    12
    Review Days
    103

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    Basic Information

    Device Name
    STAT-TRAK LIQUID ELECTROLYTE CONTROL
    K Number
    K831389
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    862.1660
    Medical Specialty
    Clinical Chemistry
    Decision
    Substantially Equivalent
    Applicant
    United Diagnostics, Inc.
    Date Received
    April 29, 1983
    Decision Date
    August 10, 1983
    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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    Other Clearances by United Diagnostics, Inc.

    K Number Device Name
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    K844018 GAS TRAK BRAND CO-OXIMETER CONTROLS 1,2 & 3
    K831813 CO-OXIMETER CONTROL
    K831814 CALIBRATION STANDARD-HEMOGLOBIN
    K831075 BLOOD GAS & FLAME PHOTOMETER INSTRU-
    K820705 GAS-TRAK 2 SYNTHETIC BLOOD GAS CONTROL
    K813517 BLOOD GAS ANALYSIS, STANDARDS CONTROLS
    K810618 AMPULED FLAME PHOTOMETER STANDARDS
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