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

    BARBITURATE ENZYME IMMUNOASSAY, CA. # 0140 (500 TESTS KIT); CAT# 0141 (5000 TESTS KIT)

    K Number: K032764 · Decision Nov 3, 2003
    View on FDA
    Classifications
    1
    FEI Numbers
    88
    Registration Numbers
    88
    Same Product Code
    99
    Applicant Total
    50
    Review Days
    59

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    Basic Information

    Device Name
    BARBITURATE ENZYME IMMUNOASSAY, CA. # 0140 (500 TESTS KIT); CAT# 0141 (5000 TESTS KIT)
    K Number
    K032764
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    862.3150
    Medical Specialty
    Clinical Toxicology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Lin-Zhi International, Inc.
    Date Received
    September 5, 2003
    Decision Date
    November 3, 2003
    Product Code
    DIS
    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
    DIS Enzyme Immunoassay, Barbiturate

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