Clearance Summary
RESUBMITTED TRIGLYCERIDE GPO REAGENT (SINGLE VIAL) received FDA 510(k) clearance under submission number K871509, 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 1987-05-08.
- Submission: K871509
- Applicant / Sponsor: Trace Scientific , Ltd.
- Clearance pathway: Traditional
- Review panel: Clinical Chemistry
- Device class: Class I
- Regulation citation: 21 CFR 862.1705
- Decision date: 1987-05-08
Classification & Regulation
This clearance is catalogued under FDA product code CDT and 21 CFR 862.1705, within the Clinical Chemistry review panel as a Class I device.