Clearance Summary
CYBOW READER, MODELS 300 & 720 received FDA 510(k) clearance under submission number K102188, 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 2011-08-09.
- Submission: K102188
- Applicant / Sponsor: DFI Co., Ltd.
- Clearance pathway: Traditional
- Review panel: Clinical Chemistry
- Device class: Class I
- Regulation citation: 21 CFR 862.2900
- Decision date: 2011-08-09
Classification & Regulation
This clearance is catalogued under FDA product code KQO and 21 CFR 862.2900, within the Clinical Chemistry review panel as a Class I device.