BEUDAMED
    FDA 510(k) FDA class 1 Substantially Equivalent 🇺🇸 United States

    WHOLE BLOOD ALCOHOL CONTROL, LEVEL 1 & 2

    K Number: K912826 · Decision Jul 26, 1991
    View on FDA
    Classifications
    1
    FEI Numbers
    10
    Registration Numbers
    10
    Same Product Code
    10
    Applicant Total
    12
    Review Days
    30

    Basic Information

    Device Name
    WHOLE BLOOD ALCOHOL CONTROL, LEVEL 1 & 2
    K Number
    K912826
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    862.3280
    Medical Specialty
    Clinical Toxicology
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    CALA DIAGNOSTICS
    Date Received
    June 26, 1991
    Decision Date
    July 26, 1991
    Product Code
    DKC
    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
    DKC Alcohol Control Materials

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