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

    COBAS STANDARD FOR TOTAL PROTEIN

    K Number: K823576 · Decision Jan 7, 1983
    View on FDA
    Classifications
    1
    FEI Numbers
    0
    Registration Numbers
    0
    Same Product Code
    14
    Applicant Total
    49
    Review Days
    32

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    Basic Information

    Device Name
    COBAS STANDARD FOR TOTAL PROTEIN
    K Number
    K823576
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    862.3880
    Medical Specialty
    Clinical Toxicology
    Decision
    Substantially Equivalent
    Applicant
    Hoffmann-La Roche, Inc.
    Date Received
    December 6, 1982
    Decision Date
    January 7, 1983
    Product Code
    LER
    Advisory Committee
    Clinical Toxicology
    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
    LER Fluorescent Immunoassay, Theophylline

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