Clearance Summary
ATAC-PAK DIRECT HDL CHOLESTEROL REAGENT AND ATAC HDL-C CALIBRATOR KITS received FDA 510(k) clearance under submission number K991789, sponsored by Elan Holdings, 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 1999-07-09.
- Submission: K991789
- Applicant / Sponsor: Elan Holdings, Inc.
- Clearance pathway: Traditional
- Review panel: Clinical Chemistry
- Device class: Class I
- Regulation citation: 21 CFR 862.1475
- Decision date: 1999-07-09
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.