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

    SUDAN IV HERXHEIMER

    K Number: K842916 · Decision Sep 11, 1984
    View on FDA
    Classifications
    1
    FEI Numbers
    4
    Registration Numbers
    4
    Same Product Code
    0
    Applicant Total
    50
    Review Days
    48

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    Basic Information

    Device Name
    SUDAN IV HERXHEIMER
    K Number
    K842916
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    864.1850
    Medical Specialty
    Hematology
    Decision
    Substantially Equivalent
    Applicant
    E K Ind., Inc.
    Date Received
    July 25, 1984
    Decision Date
    September 11, 1984
    Product Code
    KKK
    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
    KKK Sudan Iv

    Other Clearances by E K Ind., Inc.

    K Number Device Name
    K842931 DRABKIN REAGENT
    K842938 ACETIC ACID 1% V/V
    K842934 DECOLORIZING FLUIC, ACID-ALCOHOL 3%
    K842937 ACETIC ACID 2% V/V
    K842935 ACETIC ACID, 5% V/V
    K842936 ACETIC ACID, 3% V/V
    K842927 LIGHT GREEN SF 1%
    K842919 SCHIFF REAGENT FUCHSIN-SULFUROUS ACID
    K842926 METHYLENE BLUE STAIN, LOEFFLER
    K842933 CARBOL-FUCHSIN, ZIEHL-NEEDSEN
    Search all 50 clearances from E K Ind., Inc. →