BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇬🇧 United Kingdom

    VITROS Immunodiagnostic Products CK-MB Reagent Pack

    K Number: K212648 · Decision Jan 28, 2022
    View on FDA
    Classifications
    1
    FEI Numbers
    31
    Registration Numbers
    31
    Same Product Code
    47
    Applicant Total
    16
    Review Days
    158

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    Basic Information

    Device Name
    VITROS Immunodiagnostic Products CK-MB Reagent Pack
    K Number
    K212648
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    862.1215
    Medical Specialty
    Clinical Chemistry
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Ortho Clinical Diagnostics
    Date Received
    August 23, 2021
    Decision Date
    January 28, 2022
    Product Code
    JHX
    Advisory Committee
    Clinical Chemistry
    Review Advisory Committee
    CH
    Third Party
    N

    Classifications

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

    Product Code Device Name
    JHX Fluorometric Method, Cpk Or Isoenzymes

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