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

    SIGMA REAGENT SYSTEM NO. 885

    K Number: K822733 · Decision Dec 3, 1982
    View on FDA
    Classifications
    1
    FEI Numbers
    1
    Registration Numbers
    1
    Same Product Code
    0
    Applicant Total
    231
    Review Days
    86

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    Basic Information

    Device Name
    SIGMA REAGENT SYSTEM NO. 885
    K Number
    K822733
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    864.7100
    Medical Specialty
    Hematology
    Decision
    Substantially Equivalent
    Applicant
    Sigma Chemical Co.
    Date Received
    September 8, 1982
    Decision Date
    December 3, 1982
    Product Code
    JBE
    Advisory Committee
    Hematology
    Review Advisory Committee
    HE
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    JBE Cell Enzymes (Erythrocytic And Leukocytic)

    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
    K933693 SIGMA CX-3 CALIBRATION STANDARD LEVEL 2
    Search all 231 clearances from Sigma Chemical Co. →