Clearance Summary
ELECSYSCA 15-3 II ASSAY received FDA 510(k) clearance under submission number K010588, sponsored by Roche Diagnostics Corp.. The device was reviewed via the Special premarket notification pathway and assigned to the Immunology review panel. The statutory decision date of record is 2001-03-28.
- Submission: K010588
- Applicant / Sponsor: Roche Diagnostics Corp.
- Clearance pathway: Special
- Review panel: Immunology
- Device class: Class II
- Regulation citation: 21 CFR 866.6010
- Decision date: 2001-03-28
Classification & Regulation
This clearance is catalogued under FDA product code MOI and 21 CFR 866.6010, within the Immunology review panel as a Class II device.