Clearance Summary
DUS 2GP Reagent Strips, DUS 5 Reagent Strips, DUS 10 Reagent Strips received FDA 510(k) clearance under submission number K181024, sponsored by DFI Co., 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 2018-05-23.
- Submission: K181024
- Applicant / Sponsor: DFI Co., Ltd.
- Clearance pathway: Traditional
- Review panel: Clinical Chemistry
- Device class: Class II
- Regulation citation: 21 CFR 862.1340
- Decision date: 2018-05-23
Classification & Regulation
This clearance is catalogued under FDA product code JIL and 21 CFR 862.1340, within the Clinical Chemistry review panel as a Class II device.