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    FDA 510(K) K110277, RAPIDPOINT 405 NEONATAL BILIRUBIN

    FDA 510(K) K110277, RAPIDPOINT 405 NEONATAL BILIRUBIN

    $1,147.51 USD
    $1,147.51 USD
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    Device Classification Name    Bilirubin (Total And Unbound) In The Neonate Test System
    510(k) Number    K110277
    Device Name    RAPIDPOINT 405 NEONATAL BILIRUBIN
    Applicant    SIEMENS HEALTHCARE DIAGNOSTICS
    Regulation Number    862.1113
    Classification Product Code    MQM  
    Date Received    01/31/2011
    Decision Date    08/15/2011
    Decision    Substantially Equivalent (SESE)
    Regulation Medical Specialty    Clinical Chemistry

    Total pages: 969
    Fully redacted pages: 371
    Content pages: 598

    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or additional information requests, internal FDA communications, software and risk analysis, specifications, SOPs, unpublished studies, draft manuals, etc.”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.

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