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

    LABTRONIX PLATELET COUNTER(L/O/C.)

    K Number: K811084 · Decision Jul 23, 1981
    View on FDA
    Classifications
    1
    FEI Numbers
    5
    Registration Numbers
    5
    Same Product Code
    2
    Applicant Total
    2
    Review Days
    93

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    Basic Information

    Device Name
    LABTRONIX PLATELET COUNTER(L/O/C.)
    K Number
    K811084
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    864.6160
    Medical Specialty
    Hematology
    Decision
    Substantially Equivalent
    Applicant
    Labtronix Corp.
    Date Received
    April 21, 1981
    Decision Date
    July 23, 1981
    Product Code
    GLG
    Advisory Committee
    Hematology
    Review Advisory Committee
    RA
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    GLG Platelet Counting, Manual

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    Other Clearances by Labtronix Corp.

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    K812031 LPC II