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

    IPA FOR DETECTION OF PHENOBARBITAL

    K Number: K821543 · Decision Jun 3, 1982
    View on FDA
    Classifications
    1
    FEI Numbers
    2
    Registration Numbers
    2
    Same Product Code
    4
    Applicant Total
    41
    Review Days
    10

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    Basic Information

    Device Name
    IPA FOR DETECTION OF PHENOBARBITAL
    K Number
    K821543
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    862.3660
    Medical Specialty
    Clinical Toxicology
    Decision
    Substantially Equivalent
    Applicant
    Electro-Nucleonics Laboratories, Inc.
    Date Received
    May 24, 1982
    Decision Date
    June 3, 1982
    Product Code
    LFN
    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
    LFN Nephelometric Inhibition Immunoassay, Phenobarbital

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