BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇺🇸 United States

    ELIA B2-GLYCOPROTEIN I IGA IMMUNOASSAY

    K Number: K112414 · Decision Jun 22, 2012
    View on FDA
    Classifications
    1
    FEI Numbers
    19
    Registration Numbers
    19
    Same Product Code
    45
    Applicant Total
    22
    Review Days
    305

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    Basic Information

    Device Name
    ELIA B2-GLYCOPROTEIN I IGA IMMUNOASSAY
    K Number
    K112414
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    866.5660
    Medical Specialty
    Immunology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Phadia US, Inc.
    Date Received
    August 22, 2011
    Decision Date
    June 22, 2012
    Product Code
    MSV
    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
    MSV System,Test,Antibodies,B2 - Glycoprotein I (B2 - Gpi)

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    Other Clearances by Phadia US, Inc.

    K Number Device Name
    K141375 ELIA M2; IMMUNOASSAY, POSITIVE CONTROL 100, POSITIVE CONTROL 250
    K140225 ELIA PR3S IMMUNOASSAY, ELIA MPOS IMMUNOASSAY, ELIA GBM IMMUNOASSAY, ELIA ANCA/GBM POSITIVE CONTROL 100, ELIA ANCA/GBM PO
    K132631 EIA SMDP IMMUNOASSAY
    K131821 ELIA(TM) CARDIOLIPIN IGA IMMUNOASSAY
    K122197 AUTOMATED IN VITRO QUANTITATIVE ASSAY FOR THE MEASUREMENT OF ALLERGEN SPECIFIC IGE ANTIBODIES
    K113841 IMMUNOCAP ALLERGEN COMPONENTS BUNDLE
    DEN120001 IMMUNOCAP TRYPTASE, CALIBRATORS, CURVE CONTROL, CONJUGATE 50, CALIBRATOR STRIP, CURVE CONTROL STRIP, ANTI-TRYPTASE
    K111919 IMMUNOCAP SPECIFIC IGE ALLERGEN BUNDLE, 12 ALLERGEN COMPONENTS
    K102673 RHEUMATOID FACTOR IMMUNOLOGICAL TEST SYSTEM
    K093459 ELIA GLIADIN DP IGA IMMUNOASSAY AND ELIA GLIADIN DP IGG IMMUNOASSAY, MODELS 14-5538-01, 14-5539-01
    Search all 22 clearances from Phadia US, Inc. →