Clearance Summary
ANA TEST KIT received FDA 510(k) clearance under submission number K811022, sponsored by Immuno-Diagnostic Products, 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 1981-04-23.
- Submission: K811022
- Applicant / Sponsor: Immuno-Diagnostic Products, Inc.
- Clearance pathway: Traditional
- Review panel: Immunology
- Device class: Class II
- Regulation citation: 21 CFR 866.5100
- Decision date: 1981-04-23
Classification & Regulation
This clearance is catalogued under FDA product code DHN and 21 CFR 866.5100, within the Immunology review panel as a Class II device.