FDA 510(k)

Finetest Lite Blood Glucose Monitoring System

K-Number: K203562 · 2021-07-13

Decision Date2021-07-13

Product CodeNBW

Advisory CommitteeCH

DecisionSubstantially Equivalent

Device Summary

Finetest Lite Blood Glucose Monitoring System is a medical device manufactured by Osang Healthcare Co. , Ltd.. It received FDA 510(k) clearance on 2021-07-13 under approval number K203562. The device is classified under product code NBW. It was reviewed by the CH advisory panel. Product code NBW falls under the category of OB/GYN, which includes obstetric and gynecological diagnostic devices. Devices in this category are subject to specific FDA regulatory requirements. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Finetest Lite Blood Glucose Monitoring System?

Finetest Lite Blood Glucose Monitoring System is a medical device that received FDA 510(k) clearance on 2021-07-13. It is manufactured by Osang Healthcare Co. , Ltd.. The 510(k) number is K203562.

When was Finetest Lite Blood Glucose Monitoring System approved by the FDA?

Finetest Lite Blood Glucose Monitoring System received FDA 510(k) clearance on 2021-07-13, under approval number K203562.

What company makes Finetest Lite Blood Glucose Monitoring System?

Finetest Lite Blood Glucose Monitoring System is manufactured by Osang Healthcare Co. , Ltd..

What is the FDA product code for Finetest Lite Blood Glucose Monitoring System?

The FDA product code for Finetest Lite Blood Glucose Monitoring System is NBW. This falls under the OB/GYN category.

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Related PubMed Literature

PMID: 41693672 Continuous Glucose Monitoring in Diabetes Care in Saudi Arabia: Addressing Performance Standards and Regulatory Gaps-Literature Review and Consensus Report. Journal of diabetes science and technology (2026) PMID: 40388896 Accuracy and Safety of a Continuous Noninvasive Blood Pressure Monitor in Neonates. Neonatology (2025) PMID: 37948287 TCCC Decision Support With Machine Learning Prediction of Hemorrhage Risk, Shock Probability. Military medicine (2023) PMID: 37272495 An Empirical Review of Key Glucose Monitoring Devices: Product Iterations and Patent Protection. Journal of diabetes science and technology (2025)

Other Devices by Osang Healthcare Co. , Ltd.

K182286Oh'Care Lite Smart Blood Glucose Monitoring System K201396Finetest Lite Smart Blood Glucose Monitoring System

Related Devices (Code: NBW)

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.