Clearance Summary
ALT (GPT) IFCC 2-VIAL REAGENT W/PYRIDOXYL PHOSPHAT received FDA 510(k) clearance under submission number K891469, 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 1989-04-04.
- Submission: K891469
- Applicant / Sponsor: Trace Scientific , Ltd.
- Clearance pathway: Traditional
- Review panel: Clinical Chemistry
- Device class: Class I
- Regulation citation: 21 CFR 862.1030
- Decision date: 1989-04-04
Classification & Regulation
This clearance is catalogued under FDA product code CKA and 21 CFR 862.1030, within the Clinical Chemistry review panel as a Class I device.