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

    ULTRAPAK CAT. #100-0251

    K Number: K802690 · Decision Jan 8, 1981
    View on FDA
    Classifications
    1
    FEI Numbers
    0
    Registration Numbers
    0
    Same Product Code
    0
    Applicant Total
    2
    Review Days
    73

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    Basic Information

    Device Name
    ULTRAPAK CAT. #100-0251
    K Number
    K802690
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    864.1850
    Medical Specialty
    Hematology
    Decision
    Substantially Equivalent
    Applicant
    Occumedics, Inc.
    Date Received
    October 27, 1980
    Decision Date
    January 8, 1981
    Product Code
    HYG
    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
    HYG Glenner'S Stain

    Other Clearances by Occumedics, Inc.

    K Number Device Name
    K802691 OCCUPAK CAT.#200-0538