Clearance Summary
CLEX received FDA 510(k) clearance under submission number K833463, sponsored by Dextran Products, Ltd.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Hematology review panel. The statutory decision date of record is 1983-11-21.
- Submission: K833463
- Applicant / Sponsor: Dextran Products, Ltd.
- Clearance pathway: Traditional
- Review panel: Hematology
- Device class: Class I
- Regulation citation: 21 CFR 864.2800
- Decision date: 1983-11-21
Classification & Regulation
This clearance is catalogued under FDA product code KIS and 21 CFR 864.2800, within the Hematology review panel as a Class I device.