Blood Glucose Monitoring System (Glucose Oxidase)
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K113636 FDA 510(k)
- FDA Product Code
- CGA 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)
This device is a blood glucose monitoring system utilizing the glucose oxidase method. It is classified as a glucose oxidase-based system for measuring blood glucose levels, designed to assist in the management of diabetes and related conditions by providing quantitative results from capillary blood samples. The system relies on enzymatic reactions to convert glucose into measurable signals, enabling accurate monitoring of blood glucose concentrations in clinical or home settings.
The system is intended for single-use and requires calibration and testing procedures as specified by the manufacturer. It is not sterile and is supplied as a non-reusable diagnostic tool. The device is classified under FDA product code CGA and has received a 510(k) clearance for traditional review in the Clinical Chemistry specialty. No MRI safety information or specific storage conditions are provided in the regulatory data. The device is regulated under FDA regulation number 862.1345.
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: K113636 FDA 510(k) - BLOOD GLUCOSE MONITORING SYSTEM (GLUCOS..., Blood - Wikipedia, Blood Glucose Monitoring System (glucose Oxidase) 510 (k) FDA Premarket ..., PHILOSYS Co., Ltd. FDA Filings - FDA.report, Philosys Co. Ltd - 582516 - 01/14/2020 | FDA
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K113636 | Class II | Active |
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Manufacturer
- Manufacturer
- PHILOSYS Co., Ltd
- FDA Applicant
- Philosys Co., Ltd.
Sources (1)
- FDA 510(k) K113636 24 fields · synced Oct 5, 2026