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

    VITROS Chemistry Products PHBR Slides

    K Number: K210858 · Decision Aug 13, 2021
    View on FDA
    Classifications
    1
    FEI Numbers
    25
    Registration Numbers
    25
    Same Product Code
    34
    Applicant Total
    106
    Review Days
    143

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    Basic Information

    Device Name
    VITROS Chemistry Products PHBR Slides
    K Number
    K210858
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    862.3660
    Medical Specialty
    Clinical Toxicology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Ortho-Clinical Diagnostics, Inc.
    Date Received
    March 23, 2021
    Decision Date
    August 13, 2021
    Product Code
    DLZ
    Advisory Committee
    Clinical Toxicology
    Review Advisory Committee
    TX
    Third Party
    N

    Classifications

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

    Product Code Device Name
    DLZ Enzyme Immunoassay, Phenobarbital

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