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

    MCS TOTAL PROTEIN REAGENT

    K Number: K840290 · Decision Mar 30, 1984
    View on FDA
    Classifications
    1
    FEI Numbers
    42
    Registration Numbers
    42
    Same Product Code
    115
    Applicant Total
    7
    Review Days
    66

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    Basic Information

    Device Name
    MCS TOTAL PROTEIN REAGENT
    K Number
    K840290
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    862.1635
    Medical Specialty
    Clinical Chemistry
    Decision
    Substantially Equivalent
    Applicant
    Medilab Corp.
    Date Received
    January 24, 1984
    Decision Date
    March 30, 1984
    Product Code
    CEK
    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
    CEK Biuret (Colorimetric), Total Protein

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    Other Clearances by Medilab Corp.

    K Number Device Name
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    K841863 MONO-TEC
    K840291 MCS ALBUMIN REAGENT
    K840289 LYSE-TEC
    K832918 PREGNA-TEC
    K832527 PREGNA-TEC