Clearance Summary
ACETYLCHOLINE RECEPTOR AB (ARAB)RRA received FDA 510(k) clearance under submission number K051144, sponsored by Ibl-Hamburg GmbH. The device was reviewed via the Traditional premarket notification pathway and assigned to the Immunology review panel. The statutory decision date of record is 2005-11-18.
- Submission: K051144
- Applicant / Sponsor: Ibl-Hamburg GmbH
- Clearance pathway: Traditional
- Review panel: Immunology
- Device class: Class II
- Regulation citation: 21 CFR 866.5660
- Decision date: 2005-11-18
Classification & Regulation
This clearance is catalogued under FDA product code NST and 21 CFR 866.5660, within the Immunology review panel as a Class II device.