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

    VENOM TIEM REAGENT

    K Number: K955115 · Decision Apr 3, 1996
    View on FDA
    Classifications
    1
    FEI Numbers
    3
    Registration Numbers
    3
    Same Product Code
    6
    Applicant Total
    57
    Review Days
    146

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    Basic Information

    Device Name
    VENOM TIEM REAGENT
    K Number
    K955115
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    864.8100
    Medical Specialty
    Hematology
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Medical Diagnostic Technologies, Inc.
    Date Received
    November 9, 1995
    Decision Date
    April 3, 1996
    Product Code
    JCO
    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
    JCO Bothrops Atrox Reagent

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