BEUDAMED
    FDA 510(k) FDA class 1 Substantially Equivalent 🇫🇮 Finland

    QUIKREAD CRP CALIBRATOR SET

    K Number: K042625 · Decision Nov 18, 2004
    View on FDA
    Classifications
    1
    FEI Numbers
    127
    Registration Numbers
    127
    Same Product Code
    672
    Applicant Total
    4
    Review Days
    52

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    Basic Information

    Device Name
    QUIKREAD CRP CALIBRATOR SET
    K Number
    K042625
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    862.1660
    Medical Specialty
    Clinical Chemistry
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Orion Diagnostica, OY
    Date Received
    September 27, 2004
    Decision Date
    November 18, 2004
    Product Code
    JJY
    Advisory Committee
    Clinical Chemistry
    Review Advisory Committee
    CH
    Third Party
    N

    Classifications

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

    Product Code Device Name
    JJY Multi-Analyte Controls, All Kinds (Assayed)

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    Other Clearances by Orion Diagnostica, OY

    K Number Device Name
    K142993 QuikRead go CRP, QuikRead go CRP Verification Set, QuikRead go CRP Control Set, and QuikRead go Instrument
    K043125 ORION DIAGNOSTICA UNIQ PINP RIA
    K042442 QUICKREAD SYSTEM: QUICKREAD CRP KIT, MODEL 06085; QUICKREAD 101 INSTRUMENT, MODEL 06088; QUICKREAD CRP CONTROL SET, MODE