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    FDA 510(k) FDA class 2 Substantially Equivalent 🇫🇮 Finland

    ORION DIAGNOSTICA QUIKREAD CRP KIT AND QUIKREAD CRP CONTROL

    K Number: K031607 · Decision Oct 10, 2003
    View on FDA
    Classifications
    1
    FEI Numbers
    46
    Registration Numbers
    46
    Same Product Code
    125
    Applicant Total
    4
    Review Days
    141

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    Basic Information

    Device Name
    ORION DIAGNOSTICA QUIKREAD CRP KIT AND QUIKREAD CRP CONTROL
    K Number
    K031607
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    866.5270
    Medical Specialty
    Immunology
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Orion Diagnostica, Div. Orion Corp.
    Date Received
    May 22, 2003
    Decision Date
    October 10, 2003
    Product Code
    DCK
    Advisory Committee
    Immunology
    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
    DCK C-Reactive Protein, Antigen, Antiserum, And Control

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    Other Clearances by Orion Diagnostica, Div. Orion Corp.

    K Number Device Name
    K022176 ORION DIAGNOSTICA ULTRASENSITIVE CRP KIT, MODEL 68025, & ORION DIAGNOSTICA ULTRASENSITIVE CRP CONTROL, MODEL 68257
    K971537 PYLORISET EIA-G (68926)
    K942974 PYLORISET DRY