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

    LYTENING TM 6/R

    K Number: K904726 · Decision Dec 18, 1990
    View on FDA
    Classifications
    1
    FEI Numbers
    33
    Registration Numbers
    33
    Same Product Code
    28
    Applicant Total
    6
    Review Days
    62

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    Basic Information

    Device Name
    LYTENING TM 6/R
    K Number
    K904726
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    862.1145
    Medical Specialty
    Clinical Chemistry
    Decision
    Substantially Equivalent
    Applicant
    Amdev, Inc.
    Date Received
    October 17, 1990
    Decision Date
    December 18, 1990
    Product Code
    JFP
    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
    JFP Electrode, Ion Specific, Calcium

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    Other Clearances by Amdev, Inc.

    K Number Device Name
    K890524 APEC GLUCOSE ANALYZER
    K884731 LYTENING 6 SODIUM/POTASSIUM/IONIZED CALCIUM ANALYZ
    K880917 LYTENING 5
    K863521 LYTENING 2
    K853832 LYTENING 1