GAL-1A Plus Blood Glucose Monitoring System
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K213887 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 GAL-1A Plus Blood Glucose Monitoring System is an in vitro diagnostic device classified as a blood glucose test system. It is designed for the quantitative measurement of glucose levels in fresh capillary whole blood obtained from the finger, intended for use outside the body. This system aids individuals with diabetes in monitoring blood glucose concentrations as part of home diabetes management. The device operates as a standalone system for self-testing purposes.
The system is supplied as a single-use device and is intended for use by patients at home. It is not intended for reusable applications or clinical settings outside of self-monitoring. The GAL-1A Plus has received FDA 510(k) clearance under Special Controls, classified under product code NBW. No additional regulatory details beyond the provided clearance are stated in the specifications.
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: K213887 - GAL-1A Plus Blood Glucose Monitoring Sy..., GAL-1A Plus Blood Glucose Monitoring System (K213887 ... - fda ..., K113208 FDA 510(k) - GAL-1A BLOOD GLUCOSE MONITORING SYSTEM, GAL-1A Plus Blood Glucose Monitoring System - FDA 510(k) K213887
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K213887 | Class II | Active |
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Manufacturer
- Manufacturer
- Apex Biotechnology Corp.
Sources (1)
- FDA 510(k) K213887 24 fields · synced Oct 1, 2026