Clearance Summary
ANTISMOOTH MUSCLE ANTIBODY TEST SYS received FDA 510(k) clearance under submission number K810983, sponsored by Immuno-Products Industries. The device was reviewed via the Traditional premarket notification pathway and assigned to the Immunology review panel. The statutory decision date of record is 1981-05-01.
- Submission: K810983
- Applicant / Sponsor: Immuno-Products Industries
- Clearance pathway: Traditional
- Review panel: Immunology
- Device class: Class II
- Regulation citation: 21 CFR 866.5120
- Decision date: 1981-05-01
Classification & Regulation
This clearance is catalogued under FDA product code DBE and 21 CFR 866.5120, within the Immunology review panel as a Class II device.