Clearance Summary
SECOND ANTIBODY received FDA 510(k) clearance under submission number K781070, sponsored by Pcl-Ria, 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 1978-08-10.
- Submission: K781070
- Applicant / Sponsor: Pcl-Ria, Inc.
- Clearance pathway: Traditional
- Review panel: Immunology
- Device class: Class II
- Regulation citation: 21 CFR 866.5510
- Decision date: 1978-08-10
Classification & Regulation
This clearance is catalogued under FDA product code KTS and 21 CFR 866.5510, within the Immunology review panel as a Class II device.