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

    BUFFERED SALINE

    K Number: K842722 · Decision Sep 11, 1984
    View on FDA
    Classifications
    1
    FEI Numbers
    31
    Registration Numbers
    31
    Same Product Code
    6
    Applicant Total
    50
    Review Days
    60

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    Basic Information

    Device Name
    BUFFERED SALINE
    K Number
    K842722
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    864.4010
    Medical Specialty
    Pathology
    Decision
    Substantially Equivalent
    Applicant
    E K Ind., Inc.
    Date Received
    July 13, 1984
    Decision Date
    September 11, 1984
    Product Code
    JCE
    Advisory Committee
    Pathology
    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
    JCE Solution, Isotonic

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    K842919 SCHIFF REAGENT FUCHSIN-SULFUROUS ACID
    K842926 METHYLENE BLUE STAIN, LOEFFLER
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