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

    AUTOMATED ANALYSIS ASSAY FOR BILIRUBIN IN URINE

    K Number: K951877 · Decision May 14, 1996
    View on FDA
    Classifications
    1
    FEI Numbers
    64
    Registration Numbers
    64
    Same Product Code
    45
    Applicant Total
    7
    Review Days
    403

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    Basic Information

    Device Name
    AUTOMATED ANALYSIS ASSAY FOR BILIRUBIN IN URINE
    K Number
    K951877
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    862.2900
    Medical Specialty
    Clinical Chemistry
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Chimera Research & Chemical, Inc.
    Date Received
    April 7, 1995
    Decision Date
    May 14, 1996
    Product Code
    KQO
    Advisory Committee
    Clinical Chemistry
    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
    KQO Automated Urinalysis System

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    Other Clearances by Chimera Research & Chemical, Inc.

    K Number Device Name
    K970087 CR PERFECT
    K953393 TOX PERFECT A TUBE
    K952501 TOX PERFECT B TUBES AND REAGENTS
    K950142 CR PERFECT
    K940768 AD PERFECT
    K935408 UA PERFECT