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Precision Xceed Pro Blood Glucose And B-Ketone Monitoring System With (Bgms:709…
FDA 510(k)Class II (US FDA 510(k))
510(k) K080960
Identifiers
- 510(k) Number
- K080960 FDA 510(k)
- FDA Product Code
- NBW FDA 510(k)
- Models / Variants
- Bgms:70900-03 FDA 510(k)70090-02 FDA 510(k)G3ch Strips 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)
Precision Xceed Pro Blood Glucose and B-Ketone Monitoring System with models BGMS:70900-03, 70090-02, G3CH Strips is a comprehensive 2-3 paragraph SEO description written in clear, natural language.
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 | K080960 | Class II | Active |
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Manufacturer
- Manufacturer
- Abbott Diabetes Care Inc
- FDA Applicant
- Abbott Diabetes Care, Inc.
Sources (1)
- FDA 510(k) K080960 24 fields · synced Oct 7, 2026