BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇺🇸 United States

    BD FACSLyric Flow Cytometer (3-1, 4-2, 4-2-2 and 4-3-3 optical configurations), BD FACSuite Clinical Software, BD Multitest 6-Color Assays, BD Multitest 4-Color Assays, BD Multitest 6-Color TBNK

    K Number: K170974 · Decision Jul 3, 2017
    View on FDA
    Classifications
    1
    FEI Numbers
    11
    Registration Numbers
    11
    Same Product Code
    7
    Applicant Total
    134
    Review Days
    91

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    Basic Information

    Device Name
    BD FACSLyric Flow Cytometer (3-1, 4-2, 4-2-2 and 4-3-3 optical configurations), BD FACSuite Clinical Software, BD Multitest 6-Color Assays, BD Multitest 4-Color Assays, BD Multitest 6-Color TBNK
    K Number
    K170974
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    864.5220
    Medical Specialty
    Hematology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Becton, Dickinson and Company
    Date Received
    April 3, 2017
    Decision Date
    July 3, 2017
    Product Code
    OYE
    Advisory Committee
    Hematology
    Review Advisory Committee
    IM
    Third Party
    N

    Classifications

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

    Product Code Device Name
    OYE Flow Cytometric Reagents And Accessories.

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