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    FDA 510(k), K781156, DIALYSIS SYS., PDS 400 & RO 400

    FDA 510(k), K781156, DIALYSIS SYS., PDS 400 & RO 400

    $89.00 USD
    $89.00 USD
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    510(K) Number: K781156
    Device Name: DIALYSIS SYS., PDS 400 & RO 400
    Manufacturer:
    Device Classification Name: Thin Layer Chromatography, Methamphetamine
    Regulation Number: DJC
    Classification Product Code: KXA
    Date Received: 07/11/1978
    Decision Date: 10/24/1978
    Decision: Substantially Equivalent (SESE)
    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or additional information requests, internal FDA communications, software and risk analysis, specifications, SOPs, unpublished studies, draft manuals, etc.”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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