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

    SIGMA CX-3 CALIBRATION STANDARD LEVEL 2

    K Number: K933693 · Decision Oct 13, 1993
    View on FDA
    Classifications
    1
    FEI Numbers
    101
    Registration Numbers
    101
    Same Product Code
    301
    Applicant Total
    231
    Review Days
    76

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    Basic Information

    Device Name
    SIGMA CX-3 CALIBRATION STANDARD LEVEL 2
    K Number
    K933693
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    862.1150
    Medical Specialty
    Clinical Chemistry
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Sigma Chemical Co.
    Date Received
    July 29, 1993
    Decision Date
    October 13, 1993
    Product Code
    JIX
    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
    JIX Calibrator, Multi-Analyte Mixture

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    Other Clearances by Sigma Chemical Co.

    K Number Device Name
    K933694 SIGMA GLUCOSE REAGENT
    K933678 SIGMA CALCIUM REAGENT
    K933696 SIGMA ELECTROLYTE REFERENCE REAGENT
    K933679 SIGMA BUN REAGENT
    K933691 SIGMA CO2 ALKALINE BUFFER REAGENT
    K933703 SIGMA WASH CONCENTRATE SOLUTION
    K933692 SIGMA CO2 ACID REAGENT
    K933695 SIGMA ELECTROLYTE BUFFER
    K933697 SIGMA CRE REAGENT
    K933702 SIGMA CX-3 CALIBRATION STANDARD LEVEL 1
    Search all 231 clearances from Sigma Chemical Co. →