BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇨🇦 Canada

    ACETAMINOPHEN L3K ASSAY, AND ACETAMINOPHEN L3K ASSAY, MODELS 506-10, 506-30

    K Number: K081938 · Decision May 1, 2009
    View on FDA
    Classifications
    1
    FEI Numbers
    21
    Registration Numbers
    21
    Same Product Code
    35
    Applicant Total
    2
    Review Days
    297

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    Basic Information

    Device Name
    ACETAMINOPHEN L3K ASSAY, AND ACETAMINOPHEN L3K ASSAY, MODELS 506-10, 506-30
    K Number
    K081938
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    862.3030
    Medical Specialty
    Clinical Toxicology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Genzyme Diagnostics P.E.I., Inc.
    Date Received
    July 8, 2008
    Decision Date
    May 1, 2009
    Product Code
    LDP
    Advisory Committee
    Clinical Toxicology
    Review Advisory Committee
    TX
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    LDP Colorimetry, Acetaminophen

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    Other Clearances by Genzyme Diagnostics P.E.I., Inc.

    K Number Device Name
    K082210 TOTAL BILIRUBIN L3K, MODEL 295-10 AND 295-30