BGM039 Blood Glucose Monitoring System, BGM039 Link Blood Glucose Monitoring System
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K220421 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 BGM039 Blood Glucose Monitoring System is a quantitative blood glucose measurement device, classified under the nomenclature for glucose test systems. It is designed to measure glucose levels in blood and other body fluids, supporting the diagnosis and management of metabolic disorders such as diabetes mellitus, neonatal hypoglycemia, and pancreatic islet cell carcinoma.
This system is intended for single-use applications in clinical chemistry settings and has received FDA 510(k) clearance under Special review (K220421). Supplied as a sterile, disposable device, it adheres to regulatory standards for blood glucose monitoring and is intended for use in controlled medical environments. The device is categorized under product code NBW and is manufactured by Apex Biotechnology Corp.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: BGM039 Blood Glucose Monitoring System, BGM039 Link Blood Glucose ..., BGM039 Blood Glucose Monitoring System, BGM039 Link Blood Glucose ..., K220421 FDA 510(k) - BGM039 Blood Glucose Monitoring System
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K220421 | Class II | Active |
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Manufacturer
- Manufacturer
- Apex Biotechnology Corp.
Sources (1)
- FDA 510(k) K220421 24 fields · synced Oct 6, 2026