Clearance Summary
TRACE TOTAL/DIRECT BILIRUBIN REAGENT received FDA 510(k) clearance under submission number K911866, 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 1991-07-17.
- Submission: K911866
- Applicant / Sponsor: Trace Scientific , Ltd.
- Clearance pathway: Traditional
- Review panel: Clinical Chemistry
- Device class: Class II
- Regulation citation: 21 CFR 862.1110
- Decision date: 1991-07-17
Classification & Regulation
This clearance is catalogued under FDA product code CIG and 21 CFR 862.1110, within the Clinical Chemistry review panel as a Class II device.