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

    ORION DIAGNOSTICA UNIQ PINP RIA

    K Number: K043125 · Decision May 4, 2005
    View on FDA
    Classifications
    1
    FEI Numbers
    8
    Registration Numbers
    8
    Same Product Code
    25
    Applicant Total
    4
    Review Days
    173

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    Basic Information

    Device Name
    ORION DIAGNOSTICA UNIQ PINP RIA
    K Number
    K043125
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    862.1050
    Medical Specialty
    Clinical Chemistry
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Orion Diagnostica, OY
    Date Received
    November 12, 2004
    Decision Date
    May 4, 2005
    Product Code
    CIN
    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
    CIN Electrophoretic Separation, Alkaline Phosphatase Isoenzymes

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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
    K042625 QUIKREAD CRP CALIBRATOR SET
    K042442 QUICKREAD SYSTEM: QUICKREAD CRP KIT, MODEL 06085; QUICKREAD 101 INSTRUMENT, MODEL 06088; QUICKREAD CRP CONTROL SET, MODE