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

    ORTHO ANTIBODY ENHANCEMENT SOLUTION

    K Number: K791791 · Decision Oct 11, 1979
    View on FDA
    Classifications
    1
    FEI Numbers
    13
    Registration Numbers
    13
    Same Product Code
    12
    Applicant Total
    24
    Review Days
    30

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    Basic Information

    Device Name
    ORTHO ANTIBODY ENHANCEMENT SOLUTION
    K Number
    K791791
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    864.9600
    Medical Specialty
    Hematology
    Decision
    Substantially Equivalent
    Applicant
    Ortho Diagnostics, Inc.
    Date Received
    September 11, 1979
    Decision Date
    October 11, 1979
    Product Code
    KSG
    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
    KSG Media, Potentiating For In Vitro Diagnostic Use

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