Sejoy Blood Glucose Monitoring System; Sejoy Advance Link Blood Glucose Monitoring System (K240640)
Description
Sejoy Blood Glucose Monitoring System; Sejoy Advance Link Blood Glucose Monitoring System by Sejoy Biomedical Co., Ltd., an FDA 510(k) cleared clinical chemistry device.
Regulatory Information
FDA Database
View on FDA DatabaseCategories
Predicate lineage for K240640
A 510(k) clearance is granted by showing substantial equivalence to an earlier legally marketed device, called the predicate. This lineage is named in the 510(k) summary document and is not published by the FDA as a connected dataset. Sejoy Blood Glucose Monitoring System; Sejoy Advance Link Blood Glucose Monitoring System (K240640) cites 2 predicate devices and is itself cited by 1 later device.
Predicate devices cited by this clearance
| K number | Device | Applicant | Year |
|---|---|---|---|
| K222034 | RightLance Blood Lancing System | Beijing Ruicheng Medical Supplies C... | 2022 |
| K193475 | OneTouch Verio Reflect Blood Glucose Monitoring System | Lifescan Europe GmbH | 2020 |
Later devices that cite this one as their predicate
| K number | Device | Applicant | Year |
|---|---|---|---|
| K240460 | FMD Peripheral Guide Wire F-18 Flex 400 (CSU415400259) | FMD Co., Ltd. | 2024 |
Trace the full predicate network for K240640
A link appears here only where the predicate could be read from a published 510(k) summary. Where no summary exists or a reference cannot be resolved to a K number, no link is drawn, so a gap means unknown rather than none.