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

    QUICKREAD SYSTEM: QUICKREAD CRP KIT, MODEL 06085; QUICKREAD 101 INSTRUMENT, MODEL 06088; QUICKREAD CRP CONTROL SET, MODE

    K Number: K042442 · Decision Sep 24, 2004
    View on FDA
    Classifications
    1
    FEI Numbers
    46
    Registration Numbers
    46
    Same Product Code
    125
    Applicant Total
    4
    Review Days
    15

    Research this 510(k) in seconds

    The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.

    Free to try · every answer cites its records

    Ask the Research Assistant See examples

    Basic Information

    Device Name
    QUICKREAD SYSTEM: QUICKREAD CRP KIT, MODEL 06085; QUICKREAD 101 INSTRUMENT, MODEL 06088; QUICKREAD CRP CONTROL SET, MODE
    K Number
    K042442
    Device Class
    FDA class 2
    Clearance Type
    Special
    Regulation Number
    866.5270
    Medical Specialty
    Immunology
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Orion Diagnostica, OY
    Date Received
    September 9, 2004
    Decision Date
    September 24, 2004
    Product Code
    DCK
    Advisory Committee
    Immunology
    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
    DCK C-Reactive Protein, Antigen, Antiserum, And Control

    Similar 510(k) Clearances

    Other 510(k) clearances with the same product code (DCK), ordered by most recent decision date.

    K-ASSAY CRP (Ver.2)

    FDA 510(k)
    FDA Class 2 ·Immunology

    Procise CRP, ProciseDx Analyzer, ProciseDx Calibration Cartridge

    FDA 510(k)
    FDA Class 2 ·Immunology

    Yumizen C1200 CRP

    FDA 510(k)
    FDA Class 2 ·Immunology

    CRP Vario

    FDA 510(k)
    FDA Class 2 ·Immunology

    Yumizen C1200 CRP

    FDA 510(k)
    FDA Class 2 ·Immunology

    VITROS Chemistry Products hsCRP Reagent

    FDA 510(k)
    FDA Class 2 ·Immunology
    View all

    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
    K042625 QUIKREAD CRP CALIBRATOR SET