Clearance Summary
AST (GOT) IFCC 2-VIAL REAGENT W/PYRIDOXYL PHOSPHAT received FDA 510(k) clearance under submission number K891468, 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 1989-05-22.
- Submission: K891468
- Applicant / Sponsor: Trace Scientific , Ltd.
- Clearance pathway: Traditional
- Review panel: Clinical Chemistry
- Device class: Class II
- Regulation citation: 21 CFR 862.1100
- Decision date: 1989-05-22
Classification & Regulation
This clearance is catalogued under FDA product code CIT and 21 CFR 862.1100, within the Clinical Chemistry review panel as a Class II device.