Clearance Summary
HDL-ADVANCE ASSAY, CAT. NO. 278-20, 278-50A, 278-50B received FDA 510(k) clearance under submission number K041928, sponsored by Diagnostic Chemicals , Ltd.. 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 2004-11-23.
- Submission: K041928
- Applicant / Sponsor: Diagnostic Chemicals , Ltd.
- Clearance pathway: Traditional
- Review panel: Clinical Chemistry
- Device class: Class I
- Regulation citation: 21 CFR 862.1475
- Decision date: 2004-11-23
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.