Clearance Summary
ACCESS THYROGLOBULIN ANTIBODY II ASSAY, MODELS A32898 (REAGENT) AND A36920 (CALIBRATORS) received FDA 510(k) clearance under submission number K062516, sponsored by Beckman Coulter, Inc.. The device was reviewed via the Special premarket notification pathway and assigned to the Immunology review panel. The statutory decision date of record is 2006-10-05.
- Submission: K062516
- Applicant / Sponsor: Beckman Coulter, Inc.
- Clearance pathway: Special
- Review panel: Immunology
- Device class: Class II
- Regulation citation: 21 CFR 866.5870
- Decision date: 2006-10-05
Classification & Regulation
This clearance is catalogued under FDA product code JNL and 21 CFR 866.5870, within the Immunology review panel as a Class II device.