Clearance Summary
AMRESCO FLOW PAC TOTAL IRON REAGENT SET #1241 received FDA 510(k) clearance under submission number K863426, sponsored by American Research Products Co.. 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 1986-09-16.
- Submission: K863426
- Applicant / Sponsor: American Research Products Co.
- Clearance pathway: Traditional
- Review panel: Clinical Chemistry
- Device class: Class I
- Regulation citation: 21 CFR 862.1415
- Decision date: 1986-09-16
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.