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

    EM-X

    K Number: K812222 · Decision Sep 23, 1981
    View on FDA
    Classifications
    1
    FEI Numbers
    13
    Registration Numbers
    13
    Same Product Code
    12
    Applicant Total
    6
    Review Days
    47

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    Basic Information

    Device Name
    EM-X
    K Number
    K812222
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    864.9600
    Medical Specialty
    Hematology
    Decision
    Substantially Equivalent
    Applicant
    Biological Corp. of America
    Date Received
    August 7, 1981
    Decision Date
    September 23, 1981
    Product Code
    KSG
    Advisory Committee
    Hematology
    Review Advisory Committee
    IM
    Third Party
    N

    Classifications

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

    Product Code Device Name
    KSG Media, Potentiating For In Vitro Diagnostic Use

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