FORA G71A Blood Glucose Monitoring System, TD-4274 Blood Glucose Monitoring System
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K093712 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 FORA G71A Blood Glucose Monitoring System, TD-4274 Blood Glucose Monitoring System is a blood glucose test system intended for over-the-counter use. It is designed to measure glucose levels in capillary whole blood samples.
The system is supplied as a reusable meter with single-use test strips and control solutions. It requires only FORA G71a test strips and control solutions for operation. The device received FDA 510(k) clearance under K093712 and is classified under product code NBW.
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: Fora G71a Blood Glucose Monitoring System, Td-4274 Blood Glucose ..., Fora G71a Blood Glucose Monitoring System, Td-4274 Blood Glucose ..., www.accessdata.fda.gov, PDF FORA COMFORT TD-4274A_meter manual_En_311-4274100-052
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K093712 | Class II | Active |
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Manufacturer
- Manufacturer
- Taidoc Technology Corporation
Sources (1)
- FDA 510(k) K093712 24 fields · synced Oct 6, 2026