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

    BIONIKE AQ BARBITURATE TEST

    K Number: K990280 · Decision Jun 28, 1999
    View on FDA
    Classifications
    1
    FEI Numbers
    92
    Registration Numbers
    92
    Same Product Code
    99
    Applicant Total
    2
    Review Days
    151

    Basic Information

    Device Name
    BIONIKE AQ BARBITURATE TEST
    K Number
    K990280
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    862.3150
    Medical Specialty
    Clinical Toxicology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    BIONIKE, INC.
    Date Received
    January 28, 1999
    Decision Date
    June 28, 1999
    Product Code
    DIS
    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
    DIS Enzyme Immunoassay, Barbiturate

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