BEUDAMED
    FDA 510(k) FDA class 1 Substantially Equivalent 🇺🇸 United States

    SILVER STAIN REAGENT SYSTEM

    K Number: K871476 · Decision May 21, 1987
    View on FDA
    Classifications
    1
    FEI Numbers
    10
    Registration Numbers
    10
    Same Product Code
    0
    Applicant Total
    231
    Review Days
    37

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    Basic Information

    Device Name
    SILVER STAIN REAGENT SYSTEM
    K Number
    K871476
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    864.1850
    Medical Specialty
    Hematology
    Decision
    Substantially Equivalent
    Applicant
    Sigma Chemical Co.
    Date Received
    April 14, 1987
    Decision Date
    May 21, 1987
    Product Code
    LEF
    Advisory Committee
    Hematology
    Review Advisory Committee
    PA
    Third Party
    N

    Classifications

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

    Product Code Device Name
    LEF Stains, Dye Powder

    Other Clearances by Sigma Chemical Co.

    K Number Device Name
    K933694 SIGMA GLUCOSE REAGENT
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    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. →