Clearance Summary
TRACE TRANSFERRIN REAGENT received FDA 510(k) clearance under submission number K932713, 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 1993-09-30.
- Submission: K932713
- Applicant / Sponsor: Trace Scientific , Ltd.
- Clearance pathway: Traditional
- Review panel: Hematology
- Device class: Class II
- Regulation citation: 21 CFR 864.7060
- Decision date: 1993-09-30
Classification & Regulation
This clearance is catalogued under FDA product code DDQ and 21 CFR 864.7060, within the Hematology review panel as a Class II device.