Clearance Summary
Inessa System received FDA 510(k) clearance under submission number K230545, sponsored by Triple Jump Israel , Ltd.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Clinical Chemistry review panel. The statutory decision date of record is 2023-12-20.
- Submission: K230545
- Applicant / Sponsor: Triple Jump Israel , Ltd.
- Clearance pathway: Traditional
- Review panel: Clinical Chemistry
- Device class: Class II
- Regulation citation: 21 CFR 880.5730
- Decision date: 2023-12-20
Classification & Regulation
This clearance is catalogued under FDA product code QFG and 21 CFR 880.5730, within the Clinical Chemistry review panel as a Class II device.