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

    OPUS DIGITOXIN

    K Number: K935229 · Decision Dec 22, 1993
    View on FDA
    Classifications
    1
    FEI Numbers
    0
    Registration Numbers
    0
    Same Product Code
    2
    Applicant Total
    35
    Review Days
    51

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    Basic Information

    Device Name
    OPUS DIGITOXIN
    K Number
    K935229
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    862.3300
    Medical Specialty
    Clinical Toxicology
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Pb Diagnostic Systems, Inc.
    Date Received
    November 1, 1993
    Decision Date
    December 22, 1993
    Product Code
    DPG
    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
    DPG Radioimmunoassay, Digitoxin (125-I), Rabbit Antibody, Coated Tube Sep.

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