Clearance Summary
MULTIPURPOSE IMMUNOCHEMISTRY SYSTEM LA-2000 LATEX received FDA 510(k) clearance under submission number K864342, sponsored by Eiken Chemical Co., Inc.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Immunology review panel. The statutory decision date of record is 1986-12-01.
- Submission: K864342
- Applicant / Sponsor: Eiken Chemical Co., Inc.
- Clearance pathway: Traditional
- Review panel: Immunology
- Device class: Class II
- Regulation citation: 21 CFR 866.5510
- Decision date: 1986-12-01
Classification & Regulation
This clearance is catalogued under FDA product code CFN and 21 CFR 866.5510, within the Immunology review panel as a Class II device.