Lxn Corp.
United StatesFDA applicant, unverified
- Devices
- 7
What Lxn Corp. makes
Lxn Corp. manufactures diagnostic test systems and monitoring devices for blood glucose and fructosamine levels, including standalone test kits, continuous glucose monitoring systems, and charting software for personal glucose management. Their portfolio includes both single-use test strips and integrated systems designed for home or clinical use, such as the GO Glucose Monitoring System and the Duet II Glucose Control Monitoring System.
The company’s devices are regulated under the FDA’s 510(k) pathway, with products classified as either Class I or Class II. These devices are listed in the FDA’s 510(k) clearance registry, covering in vitro diagnostics and patient-monitoring technologies. The manufacturer operates from the United States.
Catalogue
Lxn Fructosamine Test Ref K955629
Regimes: 510(k) Registry: 510(k)Lxn Blood Glucose Test System Ref K960034
Regimes: 510(k) Registry: 510(k)Go Glucose Monitoring System Ref K991754
Regimes: 510(k) Registry: 510(k)Lxn Fructosamine Test System Ref K962597
Regimes: 510(k) Registry: 510(k)Duet Glucose Control Monitoring System Ref K973140
Regimes: 510(k) Registry: 510(k)Duet Ii Glucose Control Monitoring System Ref K990942
Regimes: 510(k) Registry: 510(k)Personal Glucose Control Charting System Ref K002688
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Lxn Corp. have in the registry?
The registry currently lists 7 devices for Lxn Corp.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Lxn Corp.'s devices?
Among its 7 most recently registered devices, Lxn Corp. has devices listed in FDA 510(k) (7 devices).
What risk classes do Lxn Corp.'s devices fall under?
Among its 7 most recently registered devices, the classes recorded for Lxn Corp.'s devices are Class I and Class II. Each device page shows its own class and authorisation.
What are the newest devices from Lxn Corp. in the registry?
The most recently registered devices listed for Lxn Corp. include LXN FRUCTOSAMINE TEST, LXN BLOOD GLUCOSE TEST SYSTEM, GO GLUCOSE MONITORING SYSTEM and LXN FRUCTOSAMINE TEST SYSTEM.