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

    A549 CELL CULTURE

    K Number: K955921 · Decision Feb 16, 1996
    View on FDA
    Classifications
    1
    FEI Numbers
    7
    Registration Numbers
    7
    Same Product Code
    169
    Applicant Total
    3
    Review Days
    64

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    Basic Information

    Device Name
    A549 CELL CULTURE
    K Number
    K955921
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    864.2280
    Medical Specialty
    Hematology
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Viratest Intl., Inc.
    Date Received
    December 14, 1995
    Decision Date
    February 16, 1996
    Product Code
    KIR
    Advisory Committee
    Hematology
    Review Advisory Committee
    MI
    Third Party
    N

    Classifications

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

    Product Code Device Name
    KIR Cells, Animal And Human, Cultured

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    Other Clearances by Viratest Intl., Inc.

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