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

    QuikRead go CRP, QuikRead go CRP Verification Set, QuikRead go CRP Control Set, and QuikRead go Instrument

    K Number: K142993 · Decision Mar 10, 2016
    View on FDA
    Classifications
    1
    FEI Numbers
    46
    Registration Numbers
    46
    Same Product Code
    125
    Applicant Total
    4
    Review Days
    511

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    Basic Information

    Device Name
    QuikRead go CRP, QuikRead go CRP Verification Set, QuikRead go CRP Control Set, and QuikRead go Instrument
    K Number
    K142993
    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, OY
    Date Received
    October 16, 2014
    Decision Date
    March 10, 2016
    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, OY

    K Number Device Name
    K043125 ORION DIAGNOSTICA UNIQ PINP RIA
    K042625 QUIKREAD CRP CALIBRATOR SET
    K042442 QUICKREAD SYSTEM: QUICKREAD CRP KIT, MODEL 06085; QUICKREAD 101 INSTRUMENT, MODEL 06088; QUICKREAD CRP CONTROL SET, MODE