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

    OPUS NAPA

    K Number: K934705 · Decision Nov 22, 1993
    View on FDA
    Classifications
    1
    FEI Numbers
    7
    Registration Numbers
    7
    Same Product Code
    20
    Applicant Total
    35
    Review Days
    53

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    Basic Information

    Device Name
    OPUS NAPA
    K Number
    K934705
    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
    September 30, 1993
    Decision Date
    November 22, 1993
    Product Code
    LAN
    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
    LAN Enzyme Immunoassay, N-Acetylprocainamide

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    Other Clearances by Pb Diagnostic Systems, Inc.

    K Number Device Name
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    K935229 OPUS DIGITOXIN
    K933675 OPUS TOTAL CK
    K933066 OPUS ESTRADIOL
    K932279 OPUS(R) TOTAL B-HCG TEST SYSTEM
    K926131 OPUS MAGNUM ANALYZER
    K924957 OPUS(R) VANCOMYCIN
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