Clearance Summary
TRIGLYCERIDES (GPO-TRINDER) received FDA 510(k) clearance under submission number K880628, sponsored by Tech-Co, Inc.. 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 1988-03-15.
- Submission: K880628
- Applicant / Sponsor: Tech-Co, Inc.
- Clearance pathway: Traditional
- Review panel: Clinical Chemistry
- Device class: Class I
- Regulation citation: 21 CFR 862.1705
- Decision date: 1988-03-15
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.