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

    DU PONT STERICELL CELL CULTURE SYSTEM

    K Number: K871324 · Decision Apr 14, 1987
    View on FDA
    Classifications
    1
    FEI Numbers
    31
    Registration Numbers
    31
    Same Product Code
    12
    Applicant Total
    253
    Review Days
    11

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    Basic Information

    Device Name
    DU PONT STERICELL CELL CULTURE SYSTEM
    K Number
    K871324
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    864.2240
    Medical Specialty
    Hematology
    Decision
    Substantially Equivalent
    Applicant
    E.I. Dupont DE Nemours & Co., Inc.
    Date Received
    April 3, 1987
    Decision Date
    April 14, 1987
    Product Code
    KJA
    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
    KJA Flask, Tissue Culture

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