Clearance Summary
ANTI-ENA TEST received FDA 510(k) clearance under submission number K831292, sponsored by Meloy 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 1983-07-18.
- Submission: K831292
- Applicant / Sponsor: Meloy Laboratories, Inc.
- Clearance pathway: Traditional
- Review panel: Immunology
- Device class: Class II
- Regulation citation: 21 CFR 866.5100
- Decision date: 1983-07-18
Classification & Regulation
This clearance is catalogued under FDA product code LKO and 21 CFR 866.5100, within the Immunology review panel as a Class II device.