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

    KM-KAL L4

    K Number: K823045 · Decision Nov 5, 1982
    View on FDA
    Classifications
    1
    FEI Numbers
    101
    Registration Numbers
    101
    Same Product Code
    301
    Applicant Total
    12
    Review Days
    21

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    Basic Information

    Device Name
    KM-KAL L4
    K Number
    K823045
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    862.1150
    Medical Specialty
    Clinical Chemistry
    Decision
    Substantially Equivalent
    Applicant
    Kmn Products, Inc.
    Date Received
    October 15, 1982
    Decision Date
    November 5, 1982
    Product Code
    JIX
    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
    JIX Calibrator, Multi-Analyte Mixture

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    Other Clearances by Kmn Products, Inc.

    K Number Device Name
    K823044 KM-KAL L3
    K823019 KM-KAL 3
    K823021 KM - KAL 5
    K823022 KM-KAL 6
    K823020 KM-KAL 4
    K823024 KM - KAL 1
    K823025 KM - KAL 2
    K823023 KM-KAL L6
    K823043 KM-KAL L2
    K823042 KM-KAL L1
    Search all 12 clearances from Kmn Products, Inc. →