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

    MRC-5 CELL CULTURE VIAL

    K Number: K952727 · Decision Nov 20, 1995
    View on FDA
    Classifications
    1
    FEI Numbers
    7
    Registration Numbers
    7
    Same Product Code
    169
    Applicant Total
    3
    Review Days
    159

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    Basic Information

    Device Name
    MRC-5 CELL CULTURE VIAL
    K Number
    K952727
    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
    June 14, 1995
    Decision Date
    November 20, 1995
    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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