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

    CEDIA DAU LSD ASSAY

    K Number: K955814 · Decision Feb 9, 1996
    View on FDA
    Classifications
    1
    FEI Numbers
    7
    Registration Numbers
    7
    Same Product Code
    6
    Applicant Total
    107
    Review Days
    45

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    Basic Information

    Device Name
    CEDIA DAU LSD ASSAY
    K Number
    K955814
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    862.3580
    Medical Specialty
    Clinical Toxicology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Microgenics Corp.
    Date Received
    December 26, 1995
    Decision Date
    February 9, 1996
    Product Code
    DLB
    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
    DLB Radioimmunoassay, Lsd (125-I)

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