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

    BAYER VALPROIC ACID ASSAY FOR THE ACS:180 AND ADVIA CENTAUR ANALYZERS

    K Number: K013959 · Decision Jan 29, 2002
    View on FDA
    Classifications
    1
    FEI Numbers
    28
    Registration Numbers
    28
    Same Product Code
    93
    Applicant Total
    32
    Review Days
    60

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    Basic Information

    Device Name
    BAYER VALPROIC ACID ASSAY FOR THE ACS:180 AND ADVIA CENTAUR ANALYZERS
    K Number
    K013959
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    862.3200
    Medical Specialty
    Clinical Toxicology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Bayer Diagnostics Corp.
    Date Received
    November 30, 2001
    Decision Date
    January 29, 2002
    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 Bayer Diagnostics Corp.

    K Number Device Name
    K033379 BAYER SPECIAL CHEMISTRY CONTROLS
    K033380 BAYER SPECIAL CHEMISTRY CALIBRATORS
    K033007 BAYER ADVIA DIGOXIN ASSAY FOR THE INTEGRATED MODULE SYSTEM
    K031857 ADVIA CHEMISTRY ALPHA-1 ANTITRYPSIN ASSAY
    K022096 URIC ACID ASSAY FOR THE ADVIA INTEGRATED MODULAR SYSTEM
    K030452 BAYER LIGAND PLUS 1, 2, 3 CONTROLS
    K023840 ACID PHOSPHATASE ASSAY FOR THE ADVIA 1650
    K023841 AMMONIA ASSAY FOR THE ADVIA 1650
    K022177 PROSTATE SPECIFIC ANTIGEN (PSA) ASSAY FOR THE ADVIA INTEGRATED MODULAR SYSTEM
    K022329 CA 125 II ASSAY FOR THE BAYER ADVIA INTEGRATED MODULE SYSTEM
    Search all 32 clearances from Bayer Diagnostics Corp. →