Clearance Summary
DART IRON & IRON BINDING CAPACITY REAGENT received FDA 510(k) clearance under submission number K854305, sponsored by Coulter Electronics, Inc.. 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 1985-11-12.
- Submission: K854305
- Applicant / Sponsor: Coulter Electronics, Inc.
- Clearance pathway: Traditional
- Review panel: Clinical Chemistry
- Device class: Class I
- Regulation citation: 21 CFR 862.1410
- Decision date: 1985-11-12
Classification & Regulation
This clearance is catalogued under FDA product code CFM and 21 CFR 862.1410, within the Clinical Chemistry review panel as a Class I device.