Fora PocT S10/TD-4258 Blood Glucose Monitoring System
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K092688 FDA 510(k)
- FDA Product Code
- LFR 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 PocT S10/Td-4258 Blood Glucose Monitoring System is a device used for the quantitative measurement of glucose with fresh capillary whole blood from the finger and venous whole blood samples. It is a glucose monitoring system that aids in monitoring the effectiveness of diabetes control programs.
The system is intended for use by healthcare professionals in healthcare facilities and is indicated for multiple patient use. It is classified as a Class 2 device with a regulation number of 862.1345 and is substantially equivalent to other devices in the Clinical Chemistry medical specialty. The device has been assigned a product code of LFR and has an FDA 510(k) clearance with the number K092688.
Frequently asked questions
What is the Fora PocT S10/Td-4258 used for?
The Fora PocT S10/Td-4258 is used for the quantitative measurement of glucose in fresh capillary whole blood from the finger and venous whole blood samples, aiding in monitoring the effectiveness of diabetes control programs.
Is the Fora PocT S10/Td-4258 intended for single or multiple patient use?
The Fora PocT S10/Td-4258 is intended for multiple patient use by healthcare professionals in healthcare facilities.
What regulatory classification does the Fora PocT S10/Td-4258 have?
The Fora PocT S10/Td-4258 is classified as a Class 2 device with a regulation number of 862.1345.
What is the product code for the Fora PocT S10/Td-4258?
The product code for the Fora PocT S10/Td-4258 is LFR.
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 Poct S10/Td-4258 Blood Glucose Monitoring System (K092688) — Fda ..., FORA POCT S10/TD-4258 BLOOD GLUCOSE MONITORING SYSTEM 510 (k) K092688 ..., PDF TD-4258C_DM - TaiDoc.com
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K092688 | Class II | Active |
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Manufacturer
- Manufacturer
- Taidoc Technology Corporation
Sources (1)
- FDA 510(k) K092688 24 fields · synced Oct 6, 2026