OKmeter Match Blood Glucose Monitoring System
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K090609 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 OKmeter Match Blood Glucose Monitoring System is a device used for measuring blood glucose levels. It is designed to provide accurate readings for blood sugar monitoring purposes.
The system is supplied by OK Biotech Co., Ltd. and has received FDA 510(k) clearance with the product code NBW. It is intended for use in clinical chemistry settings and is available in various models as specified by the manufacturer.
Frequently asked questions
What is the OKmeter Match Blood Glucose Monitoring System used for?
The OKmeter Match Blood Glucose Monitoring System is designed for measuring blood glucose levels to provide accurate readings for blood sugar monitoring purposes in clinical chemistry settings.
How is the OKmeter Match Blood Glucose Monitoring System supplied?
The system is supplied by OK Biotech Co., Ltd. and is available in various models as specified by the manufacturer to meet different clinical needs.
What is the regulatory status of the OKmeter Match Blood Glucose Monitoring System?
The OKmeter Match Blood Glucose Monitoring System has received FDA 510(k) clearance with the product code NBW, indicating it is substantially equivalent to predicate devices in clinical chemistry applications.
What models are available for the OKmeter Match Blood Glucose Monitoring System?
The system is available in various models as specified by the manufacturer, though specific model details would need to be obtained directly from OK Biotech Co., Ltd.
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: OKmeter Match Blood Glucose Monitoring System, Blood Glucose Meter - OK ..., Blood Glucose Monitoring System - OK Biotech Co., Ltd., OKmeter Match Blood Glucose Meter / Blood Glucose Monitoring System ..., OKMETER MATCH BLOOD GLUCOSE MONITORING SYSTEM by OK BIOTECH CO., LTD ...
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K090609 | Class II | Active |
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Manufacturer
- Manufacturer
- Ok Biotech Co., Ltd.
Sources (1)
- FDA 510(k) K090609 24 fields · synced Sep 26, 2026