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    FDA 510(k), K221007, cobas HCV

    FDA 510(k), K221007, cobas HCV

    $1,256.00 USD
    $1,256.00 USD
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    510(K) Number: K221007
    Device Name: cobas HCV
    Manufacturer: Roche Molecular Systems, Inc.
    Device Classification Name: Assay, Hybridization And/Or Nucleic Acid Amplification For Detection Of Hepatitis C Rna,Hepatitis C Virus
    Regulation Number: 866.3170
    Classification Product Code: MZP
    Date Received: 04/05/2022
    Decision Date: 11/04/2022
    Regulation Medical Specialty: Microbiology

    668 pages (4,314 of 4,982 pages are fully redacted)

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or additional information requests, internal FDA communications, software and risk analysis, specifications, SOPs, unpublished studies, draft manuals, etc.”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