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

    TOTAL PROTEIN LIQUID STABLE REAGENT SET

    K Number: K851877 · Decision May 20, 1985
    View on FDA
    Classifications
    1
    FEI Numbers
    42
    Registration Numbers
    42
    Same Product Code
    115
    Applicant Total
    107
    Review Days
    21

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    Basic Information

    Device Name
    TOTAL PROTEIN LIQUID STABLE REAGENT SET
    K Number
    K851877
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    862.1635
    Medical Specialty
    Clinical Chemistry
    Decision
    Substantially Equivalent
    Applicant
    Medical Analysis Systems, Inc.
    Date Received
    April 29, 1985
    Decision Date
    May 20, 1985
    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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    K032826 MAS PAR TDM
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    K031890 MAS BILIRUBIN LIQUID ASSAYED BILIRUBIN CONTROL
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    K031392 MAS TOX AMMONIA CONTROLLIQUID ASSAYED TOX AMMONIA CONTROL
    K031364 MAS CARDIOLMMUNE PROBNP LIQUID ASSAYED CARDIAC MARKER CONTROL LEVEL 1, 2 AND 3
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