Clearance Summary
DIRECT HDL CHOLESTEROL AND DIRECT HDL/LDL CALIBRATOR received FDA 510(k) clearance under submission number K050823, sponsored by Teco Diagnostics. 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 2005-07-26.
- Submission: K050823
- Applicant / Sponsor: Teco Diagnostics
- Clearance pathway: Traditional
- Review panel: Clinical Chemistry
- Device class: Class I
- Regulation citation: 21 CFR 862.1475
- Decision date: 2005-07-26
Classification & Regulation
This clearance is catalogued under FDA product code LBR and 21 CFR 862.1475, within the Clinical Chemistry review panel as a Class I device.