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

    ACID PHOSPHATASE ASSAY FOR THE ADVIA 1650

    K Number: K023840 · Decision Jan 7, 2003
    View on FDA
    Classifications
    1
    FEI Numbers
    8
    Registration Numbers
    8
    Same Product Code
    23
    Applicant Total
    32
    Review Days
    50

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    Basic Information

    Device Name
    ACID PHOSPHATASE ASSAY FOR THE ADVIA 1650
    K Number
    K023840
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    862.1020
    Medical Specialty
    Clinical Chemistry
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Bayer Diagnostics Corp.
    Date Received
    November 18, 2002
    Decision Date
    January 7, 2003
    Product Code
    CKB
    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
    CKB Acid Phosphatase, Naphthyl Phosphate

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    Other Clearances by Bayer Diagnostics Corp.

    K Number Device Name
    K033379 BAYER SPECIAL CHEMISTRY CONTROLS
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    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
    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
    K023184 ETHANOL ASSAY FOR THE BAYER ADVIA INTEGRATED MODULE SYSTEM
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