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

    MICRO-MAT SYSTEM

    K Number: K854121 · Decision Oct 31, 1985
    View on FDA
    Classifications
    1
    FEI Numbers
    4
    Registration Numbers
    4
    Same Product Code
    5
    Applicant Total
    1
    Review Days
    22

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    Basic Information

    Device Name
    MICRO-MAT SYSTEM
    K Number
    K854121
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    864.5850
    Medical Specialty
    Hematology
    Decision
    Substantially Equivalent
    Applicant
    Prevo Micro-Mat System
    Date Received
    October 9, 1985
    Decision Date
    October 31, 1985
    Product Code
    GKJ
    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
    GKJ Spinner, Slide, Automated

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