Clearance Summary
ANTI-DS/N-DNA TEST KIT received FDA 510(k) clearance under submission number K801960, 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 1980-10-10.
- Submission: K801960
- Applicant / Sponsor: Immuno-Diagnostic Products, Inc.
- Clearance pathway: Traditional
- Review panel: Immunology
- Device class: Class II
- Regulation citation: 21 CFR 866.5660
- Decision date: 1980-10-10
Classification & Regulation
This clearance is catalogued under FDA product code DBL and 21 CFR 866.5660, within the Immunology review panel as a Class II device.