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

    ELVI-AMINOLEVULINIC ACID

    K Number: K792407 · Decision Jan 16, 1980
    View on FDA
    Classifications
    1
    FEI Numbers
    0
    Registration Numbers
    0
    Same Product Code
    1
    Applicant Total
    66
    Review Days
    51

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    Basic Information

    Device Name
    ELVI-AMINOLEVULINIC ACID
    K Number
    K792407
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    862.3550
    Medical Specialty
    Clinical Toxicology
    Decision
    Substantially Equivalent
    Applicant
    Volu Sol Medical Industries
    Date Received
    November 26, 1979
    Decision Date
    January 16, 1980
    Product Code
    DIJ
    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
    DIJ Lead, Delta Amino Levulinic Acid

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