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

    TRYPAN BLUE (0.5% IN NORMAL SALINE)

    K Number: K810782 · Decision May 13, 1981
    View on FDA
    Classifications
    1
    FEI Numbers
    7
    Registration Numbers
    7
    Same Product Code
    0
    Applicant Total
    75
    Review Days
    51

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    Basic Information

    Device Name
    TRYPAN BLUE (0.5% IN NORMAL SALINE)
    K Number
    K810782
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    864.1850
    Medical Specialty
    Hematology
    Decision
    Substantially Equivalent
    Applicant
    Dutchland Laboratories, Inc.
    Date Received
    March 23, 1981
    Decision Date
    May 13, 1981
    Product Code
    LGY
    Advisory Committee
    Hematology
    Review Advisory Committee
    CH
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    LGY Trypan Blue

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