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

    OPUS PROCAINAMIDE TEST SYSTEM

    K Number: K934762 · Decision Jul 20, 1994
    View on FDA
    Classifications
    1
    FEI Numbers
    8
    Registration Numbers
    8
    Same Product Code
    24
    Applicant Total
    35
    Review Days
    289

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    Basic Information

    Device Name
    OPUS PROCAINAMIDE TEST SYSTEM
    K Number
    K934762
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    862.3320
    Medical Specialty
    Clinical Toxicology
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Pb Diagnostic Systems, Inc.
    Date Received
    October 4, 1993
    Decision Date
    July 20, 1994
    Product Code
    LAR
    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
    LAR Enzyme Immunoassay, Procainamide

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