FDA 510(k), K191595, ARCHITECT STAT High Sensitivity Troponin-I

FDA 510(k), K191595, ARCHITECT STAT High Sensitivity Troponin-I

Regular price $2,041.92 USD
Regular price Sale price $2,041.92 USD
Sale Sold out

510(K) Number: K191595
Device Name: ARCHITECT STAT High Sensitivity Troponin-I
Manufacturer: Abbott Laboratories Diagnostics Division
Device Classification Name: immunoassay method, troponin subunit
Regulation Number: 862.1215
Classification Product Code: MMI
Date Received: 06/17/2019
Decision Date: 09/13/2019
Regulation Medical Specialty: Clinical Chemistry

Total pages: 4,500
Fully redacted pages: 3,328
Content pages: 1,172

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or additional information requests, internal FDA communications, software and risk analysis, specifications, SOPs, unpublished studies, draft manuals, etc.”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

View full details