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

    MASSON TRICHROME STAIN HT15

    K Number: K833273 · Decision Oct 31, 1983
    View on FDA
    Classifications
    1
    FEI Numbers
    7
    Registration Numbers
    7
    Same Product Code
    1
    Applicant Total
    231
    Review Days
    40

    Research this 510(k) in seconds

    The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.

    Free to try · every answer cites its records

    Ask the Research Assistant See examples

    Basic Information

    Device Name
    MASSON TRICHROME STAIN HT15
    K Number
    K833273
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    864.1850
    Medical Specialty
    Hematology
    Decision
    Substantially Equivalent
    Applicant
    Sigma Chemical Co.
    Date Received
    September 21, 1983
    Decision Date
    October 31, 1983
    Product Code
    ICN
    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
    ICN Biebrich Scarlet

    Similar 510(k) Clearances

    Other 510(k) clearances with the same product code (ICN), ordered by most recent decision date.

    VOLU-SOL SINGLE DIFFERENTIAL STAIN

    FDA 510(k)
    FDA Class 1 ·Hematology
    View all

    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. →