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

    MODIFIED POLYCHROME IV STAIN

    K Number: K894045 · Decision Jul 25, 1989
    View on FDA
    Classifications
    1
    FEI Numbers
    16
    Registration Numbers
    16
    Same Product Code
    0
    Applicant Total
    4
    Review Days
    48

    Basic Information

    Device Name
    MODIFIED POLYCHROME IV STAIN
    K Number
    K894045
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    864.1850
    Medical Specialty
    Hematology
    Decision
    Substantially Equivalent
    Applicant
    Devetec, Inc.
    Date Received
    June 7, 1989
    Decision Date
    July 25, 1989
    Product Code
    KFD
    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
    KFD Aniline Blue

    Other Clearances by Devetec, Inc.

    K Number Device Name
    K873594 TIF FECAL TEST
    K870988 PRICE'S ACID-FAST STAIN
    K854176 POLYCHROME IV STAIN