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

    AVI-D CONTROL

    K Number: K811713 · Decision Oct 23, 1981
    View on FDA
    Classifications
    1
    FEI Numbers
    22
    Registration Numbers
    22
    Same Product Code
    11
    Applicant Total
    126
    Review Days
    128

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    Basic Information

    Device Name
    AVI-D CONTROL
    K Number
    K811713
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    864.9650
    Medical Specialty
    Hematology
    Decision
    Substantially Equivalent
    Applicant
    Ortho Diagnostic Systems, Inc.
    Date Received
    June 17, 1981
    Decision Date
    October 23, 1981
    Product Code
    KSF
    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
    KSF Kit, Quality Control For Blood Banking Reagents

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