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

    BIOTROL CK MONOEACTIF

    K Number: K881267 · Decision May 16, 1988
    View on FDA
    Classifications
    1
    FEI Numbers
    31
    Registration Numbers
    31
    Same Product Code
    47
    Applicant Total
    46
    Review Days
    53

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    Basic Information

    Device Name
    BIOTROL CK MONOEACTIF
    K Number
    K881267
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    862.1215
    Medical Specialty
    Clinical Chemistry
    Decision
    Substantially Equivalent
    Applicant
    Biotrol, USA, Inc.
    Date Received
    March 24, 1988
    Decision Date
    May 16, 1988
    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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