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

    EKTACHEM CLINICAL CHEMISTRY SLIDE FOR ACETAMINOPHEN

    K Number: K954933 · Decision Dec 18, 1995
    View on FDA
    Classifications
    1
    FEI Numbers
    21
    Registration Numbers
    21
    Same Product Code
    35
    Applicant Total
    33
    Review Days
    52

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    Basic Information

    Device Name
    EKTACHEM CLINICAL CHEMISTRY SLIDE FOR ACETAMINOPHEN
    K Number
    K954933
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    862.3030
    Medical Specialty
    Clinical Toxicology
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Johnson & Johnson Clinical Diagnostics, Inc.
    Date Received
    October 27, 1995
    Decision Date
    December 18, 1995
    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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