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

    OPUS PROCAINAMIDE

    K Number: K951434 · Decision Jul 3, 1995
    View on FDA
    Classifications
    1
    FEI Numbers
    8
    Registration Numbers
    8
    Same Product Code
    24
    Applicant Total
    145
    Review Days
    97

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    Basic Information

    Device Name
    OPUS PROCAINAMIDE
    K Number
    K951434
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    862.3320
    Medical Specialty
    Clinical Toxicology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Behring Diagnostics, Inc.
    Date Received
    March 28, 1995
    Decision Date
    July 3, 1995
    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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    Other Clearances by Behring Diagnostics, Inc.

    K Number Device Name
    K973832 OPUS HLH CONTROLS
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    K972840 N ANTISERUM TO HUMAN TRANSFERRIN
    K973202 MODIFICATION OF OPUS FERRITIN TEST SYSTEM
    K972316 OPUS D-DIMER
    K972116 VON WILLEBRAND REAGENT
    K972011 OPUS ETHANOL
    K971600 EMIT CALIBRATOR B LEVEL 1 (CUTOFF)/EMIT CALIBRATOR B LEVEL 2 (HIGH)
    K971596 EMIT II OPIATES 300/2000 ASSAY
    K964595 OPUS PSA TEST SYSTEM
    Search all 145 clearances from Behring Diagnostics, Inc. →