Clearance Summary
AUTOMATED HDL CHOLESTEROL FLEX REAGENT CARTRIDGE, MODEL DF48A received FDA 510(k) clearance under submission number K053157, sponsored by Dade Behring, Inc.. The device was reviewed via the Special premarket notification pathway and assigned to the Clinical Chemistry review panel. The statutory decision date of record is 2005-12-09.
- Submission: K053157
- Applicant / Sponsor: Dade Behring, Inc.
- Clearance pathway: Special
- Review panel: Clinical Chemistry
- Device class: Class I
- Regulation citation: 21 CFR 862.1475
- Decision date: 2005-12-09
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.