Clearance Summary
ELECSYS IGE II IMMUNOASSAY received FDA 510(k) clearance under submission number K061970, sponsored by Roche Diagnostics. The device was reviewed via the Special premarket notification pathway and assigned to the Immunology review panel. The statutory decision date of record is 2006-08-31.
- Submission: K061970
- Applicant / Sponsor: Roche Diagnostics
- Clearance pathway: Special
- Review panel: Immunology
- Device class: Class II
- Regulation citation: 21 CFR 866.5510
- Decision date: 2006-08-31
Classification & Regulation
This clearance is catalogued under FDA product code JHR and 21 CFR 866.5510, within the Immunology review panel as a Class II device.