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

    AED CALIBRATORS

    K Number: K961273 · Decision May 15, 1996
    View on FDA
    Classifications
    1
    FEI Numbers
    28
    Registration Numbers
    28
    Same Product Code
    93
    Applicant Total
    66
    Review Days
    43

    Basic Information

    Device Name
    AED CALIBRATORS
    K Number
    K961273
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    862.3200
    Medical Specialty
    Clinical Toxicology
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    DIAGNOSTIC REAGENTS, INC.
    Date Received
    April 2, 1996
    Decision Date
    May 15, 1996
    Product Code
    DKB
    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
    DKB Calibrators, Drug Mixture

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    Other Clearances by DIAGNOSTIC REAGENTS, INC.

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