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

    BD FACSCanto II flow cytometer (4-2-2 and 5-3 configurations), BD FACSCanto flow cytometer (4-3-3 configuration)

    K Number: K141468 · Decision Feb 27, 2015
    View on FDA
    Classifications
    1
    FEI Numbers
    11
    Registration Numbers
    11
    Same Product Code
    7
    Applicant Total
    10
    Review Days
    269

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    Basic Information

    Device Name
    BD FACSCanto II flow cytometer (4-2-2 and 5-3 configurations), BD FACSCanto flow cytometer (4-3-3 configuration)
    K Number
    K141468
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    864.5220
    Medical Specialty
    Hematology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Bd Biosciences
    Date Received
    June 3, 2014
    Decision Date
    February 27, 2015
    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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    Other Clearances by Bd Biosciences

    K Number Device Name
    K090967 BD MULTITEST 6-COLOR TBNK REAGENT, MODEL 644611
    K081213 BD FACSCOUNT CD4 REAGENTS WITH MODEL 339010
    K071141 BD TRITEST CD3/CD4/CD45 WITH BD TRUCOUNT ABSOLUTE COUNT TUBES, MODEL 340402
    K071143 BD TRITEST CD3/CD4/CD45, MODEL 340383
    K062087 BD FACSCANTO II FLOW CYTOMETER, MODEL 338960; (5-3), MODEL 339473; (4-2-2), MODEL 338962
    K060375 BD MULTITEST 6-COLOR TBNK REAGENT WITH BD TRUCOUNT TUBES WITH MODELS 337 AND 166
    K041074 BD FACSCANTO WITH BD FACSANTO SOFTWARE
    K000611 STELLER CD61 ASSAY FOR USE ON THE IMAGN 2000 MICROVOLUME FLUORIMETER
    K000897 CALIBRITE PERCP-CY5.5 BEADS AND FACSCOMP SOFTWARE