Finetest Lite Blood Glucose Monitoring System

FDA 510(k) K203562 · Osang Healthcare Co. , Ltd.

Substantially Equivalent

510(k) numberK203562

Submission

Device name
Finetest Lite Blood Glucose Monitoring System
Applicant
Osang Healthcare Co. , Ltd.
Anyang, KR
Received
December 7, 2020
Decision date
July 13, 2021
Decision
Substantially Equivalent (SESE)
Type
Special 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
NBW – System, Test, Blood Glucose, Over The Counter
Device class
Class II (moderate risk)
Regulation
21 CFR 862.1345
Specialty
Clinical Chemistry

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More from Ascensia Diabetes Care

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Questions and answers

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

Finetest Lite Blood Glucose Monitoring System (K203562) received a 510(k) decision of Substantially Equivalent on July 13, 2021, 218 days after the submission was received.

What is the product code of K203562?

The FDA product code is NBW – System, Test, Blood Glucose, Over The Counter, a Class II (moderate risk) device regulated under 21 CFR 862.1345.