Clearance Summary
DIRECT LDL CHOLESTEROL IMMUNOSEPARATION REAGENT KIT received FDA 510(k) clearance under submission number K943150, sponsored by Genzyme Corp.. 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 1995-03-15.
- Submission: K943150
- Applicant / Sponsor: Genzyme Corp.
- Clearance pathway: Traditional
- Review panel: Clinical Chemistry
- Device class: Class I
- Regulation citation: 21 CFR 862.1475
- Decision date: 1995-03-15
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.