Clearance Summary
DIRECT LDL received FDA 510(k) clearance under submission number K981303, sponsored by Abbott Laboratories. 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 1998-08-03.
- Submission: K981303
- Applicant / Sponsor: Abbott Laboratories
- Clearance pathway: Traditional
- Review panel: Clinical Chemistry
- Device class: Class I
- Regulation citation: 21 CFR 862.1475
- Decision date: 1998-08-03
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.