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    FDA 510(k), K201778, i-STAT TBI Plasma cartridge with the i-STAT Alinity System

    FDA 510(k), K201778, i-STAT TBI Plasma cartridge with the i-STAT Alinity System

    $89.00 USD
    $89.00 USD
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    510(K) Number: K201778
    Device Name: i-STAT TBI Plasma cartridge with the i-STAT Alinity System
    Manufacturer: Brian Ma
    Device Classification Name: Brain Trauma Assessment Test
    Regulation Number: QAT
    Classification Product Code: KXA
    Date Received: 06/30/2020
    Decision Date: 01/08/2021
    Decision: Substantially Equivalent (SESE)
    Regulation Medical Specialty: Immunology

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or additional information requests, internal FDA communications, software and risk analysis, specifications, SOPs, unpublished studies, draft manuals, etc.”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