Clearance Summary
twiist system received FDA 510(k) clearance under submission number K250930, sponsored by Deka Research & Development Corp.. The device was reviewed via the Special premarket notification pathway and assigned to the Clinical Chemistry review panel. The statutory decision date of record is 2025-04-02.
- Submission: K250930
- Applicant / Sponsor: Deka Research & Development Corp.
- Clearance pathway: Special
- Review panel: Clinical Chemistry
- Device class: Class II
- Regulation citation: 21 CFR 880.5730
- Decision date: 2025-04-02
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.