Clearance Summary
HAEMOGLOBIN REAGENT - CYANMETHAEMOGLOBIN METHOD received FDA 510(k) clearance under submission number K870363, sponsored by Trace Scientific , 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 1987-03-16.
- Submission: K870363
- Applicant / Sponsor: Trace Scientific , Ltd.
- Clearance pathway: Traditional
- Review panel: Hematology
- Device class: Class II
- Regulation citation: 21 CFR 864.7500
- Decision date: 1987-03-16
Classification & Regulation
This clearance is catalogued under FDA product code KHG and 21 CFR 864.7500, within the Hematology review panel as a Class II device.