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

    METACHROME

    K Number: K851174 · Decision May 23, 1985
    View on FDA
    Classifications
    1
    FEI Numbers
    2
    Registration Numbers
    2
    Same Product Code
    10
    Applicant Total
    2
    Review Days
    59

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    Basic Information

    Device Name
    METACHROME
    K Number
    K851174
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    864.5260
    Medical Specialty
    Hematology
    Decision
    Substantially Equivalent
    Applicant
    Potomac Medical System
    Date Received
    March 25, 1985
    Decision Date
    May 23, 1985
    Product Code
    LNJ
    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
    LNJ Analyzer, Chromosome, Automated

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