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

    ATAC PAK ALBUMIN REAGENT

    K Number: K030006 · Decision Mar 7, 2003
    View on FDA
    Classifications
    1
    FEI Numbers
    38
    Registration Numbers
    38
    Same Product Code
    119
    Applicant Total
    13
    Review Days
    64

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    Basic Information

    Device Name
    ATAC PAK ALBUMIN REAGENT
    K Number
    K030006
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    862.1035
    Medical Specialty
    Clinical Chemistry
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Elan Diagnostics
    Date Received
    January 2, 2003
    Decision Date
    March 7, 2003
    Product Code
    CIX
    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
    CIX Bromcresol Green Dye-Binding, Albumin

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    Other Clearances by Elan Diagnostics

    K Number Device Name
    K030003 ATAC DIRECT BILIRUBIN REAGENT AND CALIBRATOR
    K030014 ATAC TOTAL BILIRUBIN REAGENT
    K030621 ATAC CALIBRATOR
    K023105 ATAC CALCIUM REAGENT AND ATAC CALIBRATOR
    K030010 ATAC PAK MAGNESIUM REAGENT
    K030015 ATAC PAK PHOSPHORUS REAGENT
    K023407 ATAC PAK CREATININE REAGENT AND ATAC CALIBRATOR
    K021385 ATAC PAK BUN REAGENT
    K020575 ATAC DIRECT LDL REAGENT AND ATAC DIRECT LDL CALIBRATOR KITS
    K002285 ATAC PAK ALP REAGENT KIT
    Search all 13 clearances from Elan Diagnostics →