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

    LYTENING 5

    K Number: K880917 · Decision May 27, 1988
    View on FDA
    Classifications
    1
    FEI Numbers
    85
    Registration Numbers
    85
    Same Product Code
    161
    Applicant Total
    6
    Review Days
    85

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    Basic Information

    Device Name
    LYTENING 5
    K Number
    K880917
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    862.1665
    Medical Specialty
    Clinical Chemistry
    Decision
    Substantially Equivalent
    Applicant
    Amdev, Inc.
    Date Received
    March 3, 1988
    Decision Date
    May 27, 1988
    Product Code
    JGS
    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
    JGS Electrode, Ion Specific, Sodium

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    Other Clearances by Amdev, Inc.

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    K884731 LYTENING 6 SODIUM/POTASSIUM/IONIZED CALCIUM ANALYZ
    K863521 LYTENING 2
    K853832 LYTENING 1