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

    ABUSCREEN RADIOIMMUNOASSAY FOR LSD W/ REF STANDARD

    K Number: K860525 · Decision Apr 11, 1986
    View on FDA
    Classifications
    1
    FEI Numbers
    7
    Registration Numbers
    7
    Same Product Code
    6
    Applicant Total
    296
    Review Days
    59

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    Basic Information

    Device Name
    ABUSCREEN RADIOIMMUNOASSAY FOR LSD W/ REF STANDARD
    K Number
    K860525
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    862.3580
    Medical Specialty
    Clinical Toxicology
    Decision
    Substantially Equivalent
    Applicant
    Roche Diagnostic Systems, Inc.
    Date Received
    February 11, 1986
    Decision Date
    April 11, 1986
    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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