1 0

    FDA 510(k), K182651, HbA1c Advanced

    FDA 510(k), K182651, HbA1c Advanced

    $89.00 USD
    $89.00 USD
    Sale Sold out
    510(K) Number: K182651
    Device Name: HbA1c Advanced
    Manufacturer:
    Device Classification Name: Hemoglobin A1c Test System
    Regulation Number: 862.1373
    Classification Product Code: PDJ
    Date Received: 09/24/2018
    Decision Date: 01/16/2019
    Regulation Medical Specialty: Clinical Chemistry

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or additional information requests, internal FDA communications, software and risk analysis, specifications, SOPs, unpublished studies, draft manuals, etc.”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