Clearance Summary
ATAC DIRECT LDL REAGENT AND ATAC DIRECT LDL CALIBRATOR KITS received FDA 510(k) clearance under submission number K020575, sponsored by Elan 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 2002-04-12.
- Submission: K020575
- Applicant / Sponsor: Elan Diagnostics
- Clearance pathway: Traditional
- Review panel: Clinical Chemistry
- Device class: Class I
- Regulation citation: 21 CFR 862.1475
- Decision date: 2002-04-12
Classification & Regulation
This clearance is catalogued under FDA product code MRR and 21 CFR 862.1475, within the Clinical Chemistry review panel as a Class I device.