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

    PAP STAIN EA-65

    K Number: K842735 · Decision Sep 11, 1984
    View on FDA
    Classifications
    1
    FEI Numbers
    30
    Registration Numbers
    30
    Same Product Code
    14
    Applicant Total
    50
    Review Days
    60

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    Basic Information

    Device Name
    PAP STAIN EA-65
    K Number
    K842735
    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 13, 1984
    Decision Date
    September 11, 1984
    Product Code
    HZJ
    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
    HZJ Stain, Papanicolau

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    Other Clearances by E K Ind., Inc.

    K Number Device Name
    K842931 DRABKIN REAGENT
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    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
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