FDA 510(k), K061247, DIASORIN LIAISON TREPONEMA ASSAY

FDA 510(k), K061247, DIASORIN LIAISON TREPONEMA ASSAY

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510(K) Number: K061247
Device Name: DIASORIN LIAISON TREPONEMA ASSAY
Manufacturer:
Device Classification Name: Enzyme Linked Immunoabsorption Assay, Treponema Pallidum
Regulation Number: 866.3830
Classification Product Code: LIP
Date Received: 05/03/2006
Decision Date: 07/31/2006
Regulation Medical Specialty: Microbiology

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or additional information requests, internal FDA communications, software and risk analysis, specifications, SOPs, unpublished studies, draft manuals, etc.”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