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    FDA 510(k), K061718, INNOVACON SPECTRUM II TEST CARD

    FDA 510(k), K061718, INNOVACON SPECTRUM II TEST CARD

    $89.00 USD
    $89.00 USD
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    510(K) Number: K061718
    Device Name: INNOVACON SPECTRUM II TEST CARD
    Manufacturer:
    Device Classification Name: Enzyme Immunoassay, Amphetamine
    Regulation Number: 862.3100
    Classification Product Code: DKZ
    Date Received: 06/19/2006
    Decision Date: 11/13/2006
    Regulation Medical Specialty: Toxicology

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or additional information requests, internal FDA communications, software and risk analysis, specifications, SOPs, unpublished studies, draft manuals, etc.”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