1 0

    FDA 510(K) K171401, ELITech Clinical Systems BILIRUBIN TOTAL 4+1, ELITech Clinical Systems BILIRUBIN DIRECT 4+1

    FDA 510(K) K171401, ELITech Clinical Systems BILIRUBIN TOTAL 4+1, ELITech Clinical Systems BILIRUBIN DIRECT 4+1

    $322.33 USD
    $322.33 USD
    Sale Sold out

    Device Classification Name    Diazo Colorimetry, Bilirubin
    510(k) Number    K171401
    Device Name    ELITech Clinical Systems BILIRUBIN TOTAL 4+1, ELITech Clinical Systems BILIRUBIN DIRECT 4+1
    Applicant    ELITechGroup
    Regulation Number    862.1110
    Classification Product Code    CIG  
    Date Received    05/12/2017
    Decision Date    07/11/2017
    Decision    Substantially Equivalent (SESE)
    Regulation Medical Specialty    Clinical Chemistry

    Total pages: 230
    Fully redacted pages: 117
    Content pages: 113

    PLEASE NOTE: Most 510(k)s obtained through FOIA are heavily redacted, often omitting sections related to testing, software, manufacturing, and other technical data. Please be sure to review the total pages, redacted pages, and content pages listed in the description to get a sense of how much of the document is redacted. As the FDA FOIA office explains: “We HEAVILY REDACT the majority of the following portions of 510(k) filings: testing data, technical data, lab reports, manufacturing information, vendor information, substantive discussions regarding deficiencies or additional information requests, internal FDA communications, software and risk analysis, specifications, SOPs, unpublished studies, draft manuals, etc.” If you’d like more details about a specific document before purchasing, please contact us at info@foiadocs.com.

    View full details