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

    LITHIUM INTERNAL STANDARD 1 MEQ/L #60085

    K Number: K871185 · Decision May 28, 1987
    View on FDA
    Classifications
    1
    FEI Numbers
    72
    Registration Numbers
    72
    Same Product Code
    129
    Applicant Total
    15
    Review Days
    65

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    Basic Information

    Device Name
    LITHIUM INTERNAL STANDARD 1 MEQ/L #60085
    K Number
    K871185
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    862.1150
    Medical Specialty
    Clinical Chemistry
    Decision
    Substantially Equivalent
    Applicant
    In Vitro Diagnostics, Inc.
    Date Received
    March 24, 1987
    Decision Date
    May 28, 1987
    Product Code
    JIS
    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
    JIS Calibrator, Primary

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    K871182 FLAME PHOTOMETER STANDARD #60081 120 NA/2K
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    K871188 LITHIUM INTERNAL STANDARD 1500 MEQ/L #60086
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