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

    cobas u 701 microscopy analyzer

    K Number: K200811 · Decision Nov 6, 2020
    View on FDA
    Classifications
    1
    FEI Numbers
    12
    Registration Numbers
    12
    Same Product Code
    14
    Applicant Total
    183
    Review Days
    224

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    Basic Information

    Device Name
    cobas u 701 microscopy analyzer
    K Number
    K200811
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    864.5200
    Medical Specialty
    Hematology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Roche Diagnostics
    Date Received
    March 27, 2020
    Decision Date
    November 6, 2020
    Product Code
    LKM
    Advisory Committee
    Hematology
    Review Advisory Committee
    HE
    Third Party
    N

    Classifications

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

    Product Code Device Name
    LKM Counter, Urine Particle

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