Clearance Summary
POLY-CHEM 90 DIRECT HDL CHOLESTEROL, POLY-CHEM 90 DIRECT LDL CHOLESTEROL, POLY-CHEM 90 CHOLESTEROL, POLY-CHEM 90 TRIGLYC received FDA 510(k) clearance under submission number K100550, sponsored by Polymedco, 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 2010-09-28.
- Submission: K100550
- Applicant / Sponsor: Polymedco, Inc.
- Clearance pathway: Traditional
- Review panel: Clinical Chemistry
- Device class: Class I
- Regulation citation: 21 CFR 862.1475
- Decision date: 2010-09-28
Classification & Regulation
This clearance is catalogued under FDA product code LBS and 21 CFR 862.1475, within the Clinical Chemistry review panel as a Class I device.