Clearance Summary
TEST KIT FOR DETECTION OF ANTINUCLEAR received FDA 510(k) clearance under submission number K802527, sponsored by Bartels & Stout, 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 1981-01-05.
- Submission: K802527
- Applicant / Sponsor: Bartels & Stout, Inc.
- Clearance pathway: Traditional
- Review panel: Immunology
- Device class: Class II
- Regulation citation: 21 CFR 866.5100
- Decision date: 1981-01-05
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.