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

    CEDIA DAU MULTI-DR CALIBRATOR/PRI, SEC, INTER, HIGH

    K Number: K954608 · Decision Dec 26, 1995
    View on FDA
    Classifications
    1
    FEI Numbers
    28
    Registration Numbers
    28
    Same Product Code
    93
    Applicant Total
    340
    Review Days
    83

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    Basic Information

    Device Name
    CEDIA DAU MULTI-DR CALIBRATOR/PRI, SEC, INTER, HIGH
    K Number
    K954608
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    862.3200
    Medical Specialty
    Clinical Toxicology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Boehringer Mannheim Corp.
    Date Received
    October 4, 1995
    Decision Date
    December 26, 1995
    Product Code
    DKB
    Advisory Committee
    Clinical Toxicology
    Review Advisory Committee
    CH
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    DKB Calibrators, Drug Mixture

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