BEUDAMED
    FDA 510(k) FDA class 1 Substantially Equivalent 🇺🇸 United States

    DV TEST AND DVV CONFIRM

    K Number: K940490 · Decision Apr 5, 1995
    View on FDA
    Classifications
    1
    FEI Numbers
    12
    Registration Numbers
    12
    Same Product Code
    15
    Applicant Total
    10
    Review Days
    426

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    Basic Information

    Device Name
    DV TEST AND DVV CONFIRM
    K Number
    K940490
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    864.8950
    Medical Specialty
    Hematology
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    American Diagnostica, Inc.
    Date Received
    February 3, 1994
    Decision Date
    April 5, 1995
    Product Code
    GIR
    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
    GIR Reagent, Russel Viper Venom

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