Clearance Summary
CRP-LATEX (II) SEIKEN HIGH SENSITIVITY ASSAY KIT received FDA 510(k) clearance under submission number K011958, sponsored by Denka Seiken'S. The device was reviewed via the Traditional premarket notification pathway and assigned to the Immunology review panel. The statutory decision date of record is 2001-12-04.
- Submission: K011958
- Applicant / Sponsor: Denka Seiken'S
- Clearance pathway: Traditional
- Review panel: Immunology
- Device class: Class II
- Regulation citation: 21 CFR 866.5270
- Decision date: 2001-12-04
Classification & Regulation
This clearance is catalogued under FDA product code DCN and 21 CFR 866.5270, within the Immunology review panel as a Class II device.