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

    STRATUS VANCOMYCIN FLUOROMETRIC ENZYME IMMUNOASSAY

    K Number: K874438 · Decision Jan 21, 1988
    View on FDA
    Classifications
    1
    FEI Numbers
    27
    Registration Numbers
    27
    Same Product Code
    30
    Applicant Total
    505
    Review Days
    85

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    Basic Information

    Device Name
    STRATUS VANCOMYCIN FLUOROMETRIC ENZYME IMMUNOASSAY
    K Number
    K874438
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    862.3950
    Medical Specialty
    Clinical Toxicology
    Decision
    Substantially Equivalent
    Applicant
    Baxter Healthcare Corp
    Date Received
    October 28, 1987
    Decision Date
    January 21, 1988
    Product Code
    LEH
    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
    LEH Radioimmunoassay, Vancomycin

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