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

    H 10 OR HEMATIL 10 BLOOD CELL & PLATELET COUNTER

    K Number: K883177 · Decision Nov 30, 1988
    View on FDA
    Classifications
    1
    FEI Numbers
    62
    Registration Numbers
    62
    Same Product Code
    379
    Applicant Total
    10
    Review Days
    126

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    Basic Information

    Device Name
    H 10 OR HEMATIL 10 BLOOD CELL & PLATELET COUNTER
    K Number
    K883177
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    864.5220
    Medical Specialty
    Hematology
    Decision
    Substantially Equivalent
    Applicant
    Texas Intl. Laboratories, Inc.
    Date Received
    July 27, 1988
    Decision Date
    November 30, 1988
    Product Code
    GKZ
    Advisory Committee
    Hematology
    Review Advisory Committee
    HE
    Third Party
    N

    Classifications

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

    Product Code Device Name
    GKZ Counter, Differential Cell

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