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    FDA 510(k), K083716, FIRST RESPONSE EARLY RESULT PREGNANCY TEST (OTC)

    FDA 510(k), K083716, FIRST RESPONSE EARLY RESULT PREGNANCY TEST (OTC)

    $89.00 USD
    $89.00 USD
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    510(K) Number: K083716
    Device Name: FIRST RESPONSE EARLY RESULT PREGNANCY TEST (OTC)
    Manufacturer:
    Device Classification Name: Kit, Test, Pregnancy, Hcg, Over The Counter
    Regulation Number: 862.1155
    Classification Product Code: LCX
    Date Received: 12/15/2008
    Decision Date: 06/08/2009
    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or additional information requests, internal FDA communications, software and risk analysis, specifications, SOPs, unpublished studies, draft manuals, etc.”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.

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