Clearance Summary
GEMENI IGA ASSAY received FDA 510(k) clearance under submission number K800449, sponsored by Electro-Nucleonics Laboratories, 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 1980-03-12.
- Submission: K800449
- Applicant / Sponsor: Electro-Nucleonics Laboratories, Inc.
- Clearance pathway: Traditional
- Review panel: Immunology
- Device class: Class II
- Regulation citation: 21 CFR 866.5510
- Decision date: 1980-03-12
Classification & Regulation
This clearance is catalogued under FDA product code CZP and 21 CFR 866.5510, within the Immunology review panel as a Class II device.