Clearance Summary
THE HELENA V8 IMMUNODISPLACEMENT KIT received FDA 510(k) clearance under submission number K111369, sponsored by Helena Laboratories Uk, Ltd.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Immunology review panel. The statutory decision date of record is 2012-06-26.
- Submission: K111369
- Applicant / Sponsor: Helena Laboratories Uk, Ltd.
- Clearance pathway: Traditional
- Review panel: Immunology
- Device class: Class II
- Regulation citation: 21 CFR 866.5510
- Decision date: 2012-06-26
Classification & Regulation
This clearance is catalogued under FDA product code CFF and 21 CFR 866.5510, within the Immunology review panel as a Class II device.