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

    ABC, ABC-1X, ABC(TM)

    K Number: K890482 · Decision Feb 10, 1989
    View on FDA
    Classifications
    1
    FEI Numbers
    27
    Registration Numbers
    27
    Same Product Code
    366
    Applicant Total
    1
    Review Days
    10

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    Basic Information

    Device Name
    ABC, ABC-1X, ABC(TM)
    K Number
    K890482
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    864.2220
    Medical Specialty
    Hematology
    Decision
    Substantially Equivalent
    Applicant
    Cell Ent., Inc.
    Date Received
    January 31, 1989
    Decision Date
    February 10, 1989
    Product Code
    KIT
    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
    KIT Media And Components, Synthetic Cell And Tissue Culture

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