Clearance Summary
IRON 5 X CONC REAGENT received FDA 510(k) clearance under submission number K904116, sponsored by Trace Scientific , 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 1990-09-27.
- Submission: K904116
- Applicant / Sponsor: Trace Scientific , Ltd.
- Clearance pathway: Traditional
- Review panel: Clinical Chemistry
- Device class: Class I
- Regulation citation: 21 CFR 862.1415
- Decision date: 1990-09-27
Classification & Regulation
This clearance is catalogued under FDA product code JMO and 21 CFR 862.1415, within the Clinical Chemistry review panel as a Class I device.