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FREESTYLE Lite Blood Glucose Monitoring System and Freestyle Freedom Lite Blood…
FDA 510(k)Class II (US FDA 510(k))
510(k) K092602
Identifiers
- 510(k) Number
- K092602 FDA 510(k)
- FDA Product Code
- NBW FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 862.1345 FDA 510(k)
- Regulation Number
- 862.1345 FDA 510(k)
- Advisory Committee
- Clinical Chemistry FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The FREESTYLE Lite Blood Glucose Monitoring System and Freestyle Freedom Lite Blood Glucose Monitoring System are innovative, user-friendly devices designed to provide accurate and reliable blood glucose monitoring results. These devices offer a convenient and easy-to-use solution for individuals with diabetes who want to manage their condition effectively.
Authorization Coverage (1 country)
Regulatory Authorizations
United States Active
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K092602 | Class II | Active |
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Manufacturer
- Manufacturer
- Abbott Diabetes Care Inc
- FDA Applicant
- Abbott Diabetes Care, Inc.
Sources (1)
- FDA 510(k) K092602 24 fields · synced Jun 30, 2026