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

    LEWIS BLOOD GROUP SUBSTANCE

    K Number: K771487 · Decision Nov 8, 1977
    View on FDA
    Classifications
    1
    FEI Numbers
    5
    Registration Numbers
    5
    Same Product Code
    7
    Applicant Total
    24
    Review Days
    95

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    Basic Information

    Device Name
    LEWIS BLOOD GROUP SUBSTANCE
    K Number
    K771487
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    864.9160
    Medical Specialty
    Hematology
    Decision
    Substantially Equivalent
    Applicant
    Ortho Diagnostics, Inc.
    Date Received
    August 5, 1977
    Decision Date
    November 8, 1977
    Product Code
    KSX
    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
    KSX Substance, Blood Grouping Of Non-Human Origin For In Vitro Diagnostic Use

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