Clearance Summary
ENA IGG BEADCHIP TEST SYSTEM, ARRAY IMAGING SYSTEM, MODELS 800-00025, AIS 400 received FDA 510(k) clearance under submission number K043067, sponsored by Bioarray Solutions, Ltd.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Immunology review panel. The statutory decision date of record is 2005-05-31.
- Submission: K043067
- Applicant / Sponsor: Bioarray Solutions, Ltd.
- Clearance pathway: Traditional
- Review panel: Immunology
- Device class: Class II
- Regulation citation: 21 CFR 866.5100
- Decision date: 2005-05-31
Classification & Regulation
This clearance is catalogued under FDA product code LLL and 21 CFR 866.5100, within the Immunology review panel as a Class II device.