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

    BIOTROL BILIRUBIN MONOREACTIF

    K Number: K884480 · Decision Nov 29, 1988
    View on FDA
    Classifications
    1
    FEI Numbers
    19
    Registration Numbers
    19
    Same Product Code
    98
    Applicant Total
    46
    Review Days
    35

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    Basic Information

    Device Name
    BIOTROL BILIRUBIN MONOREACTIF
    K Number
    K884480
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    862.1145
    Medical Specialty
    Clinical Chemistry
    Decision
    Substantially Equivalent
    Applicant
    Biotrol, USA, Inc.
    Date Received
    October 25, 1988
    Decision Date
    November 29, 1988
    Product Code
    CIC
    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
    CIC Cresolphthalein Complexone, Calcium

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    Other Clearances by Biotrol, USA, Inc.

    K Number Device Name
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    K921855 BIOTROL BICARBONATE STANDARDS
    K921677 BIOTROL MAGNESIUM (MAGON)
    K912795 BIOTROL UIBC REAGENT
    K910721 BIOTROL PROTEIN MULTILEVEL STANDARDS
    K905683 BIOTROL LACTATE DEHYDROGENASE (L-P)
    K905280 BIOTROL BILIRUBIN C & T CONTROL
    K894544 BIOTROL RUB-E.I.A. TEST G
    K891061 BIOTROL CALCIUM MONOREACTIF
    Search all 46 clearances from Biotrol, USA, Inc. →