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FDA 510(k) K092602, FreeStyle Lite and FreeStyle Freedom Lite Blood Glucose Monitoring Systems, by Abbott Diabetes Care, Inc.

FDA 510(k) K092602, FreeStyle Lite and FreeStyle Freedom Lite Blood Glucose Monitoring Systems, by Abbott Diabetes Care, Inc.

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510(K) Number: K092602
Device Name: FREESTYLE Lite Blood Glucose Monitoring System and Freestyle Freedom Lite Blood Glucose Monitoring System
Manufacturer: Abbott Diabetes Care, Inc.
Device Classification Name: System, Test, Blood Glucose, Over The Counter
Regulation Number: 862.1345
Classification Product Code: NBW
Date Received: 08/25/2009
Decision Date: 05/14/2010
Regulation Medical Specialty: Clinical Chemistry

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or additional information requests, internal FDA communications, software and risk analysis, specifications, SOPs, unpublished studies, draft manuals, etc.”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