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

    IMMPULSE PHENOBARBITAL ASSAY REAGENTS

    K Number: K862528 · Decision Jul 16, 1986
    View on FDA
    Classifications
    1
    FEI Numbers
    4
    Registration Numbers
    4
    Same Product Code
    11
    Applicant Total
    82
    Review Days
    14

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    Basic Information

    Device Name
    IMMPULSE PHENOBARBITAL ASSAY REAGENTS
    K Number
    K862528
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    862.3660
    Medical Specialty
    Clinical Toxicology
    Decision
    Substantially Equivalent
    Applicant
    Sclavo, Inc.
    Date Received
    July 2, 1986
    Decision Date
    July 16, 1986
    Product Code
    LGQ
    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
    LGQ Fluorescence Polarization Immunoassay, Phenobarbital

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