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

    VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HAV TOTAL REAGENT PACK,CALIBRATOR,CONTROLS

    K Number: K060678 · Decision Sep 14, 2006
    View on FDA
    Classifications
    1
    FEI Numbers
    25
    Registration Numbers
    25
    Same Product Code
    25
    Applicant Total
    106
    Review Days
    184

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    Basic Information

    Device Name
    VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HAV TOTAL REAGENT PACK,CALIBRATOR,CONTROLS
    K Number
    K060678
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    866.3310
    Medical Specialty
    Microbiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Ortho-Clinical Diagnostics, Inc.
    Date Received
    March 14, 2006
    Decision Date
    September 14, 2006
    Product Code
    LOL
    Advisory Committee
    Microbiology
    Review Advisory Committee
    MI
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    LOL Hepatitis A Test (Antibody And Igm Antibody)

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