Clearance Summary
LDL-EX SEIKEN ASSAY KIT received FDA 510(k) clearance under submission number K043264, sponsored by Denka Seiken Co., 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 2005-01-26.
- Submission: K043264
- Applicant / Sponsor: Denka Seiken Co., Ltd.
- Clearance pathway: Traditional
- Review panel: Clinical Chemistry
- Device class: Class I
- Regulation citation: 21 CFR 862.1475
- Decision date: 2005-01-26
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.