Clearance Summary
OSOM Mono Test; Sure Vue Signature Mono; ImmunoCard STAT Mono; Cardinal Health Mono II Rapid Test received FDA 510(k) clearance under submission number K181436, sponsored by SEKISUI Diagnostics, LLC. The device was reviewed via the Special premarket notification pathway and assigned to the Immunology review panel. The statutory decision date of record is 2018-06-22.
- Submission: K181436
- Applicant / Sponsor: SEKISUI Diagnostics, LLC
- Clearance pathway: Special
- Review panel: Immunology
- Device class: Class II
- Regulation citation: 21 CFR 866.5640
- Decision date: 2018-06-22
Classification & Regulation
This clearance is catalogued under FDA product code KTN and 21 CFR 866.5640, within the Immunology review panel as a Class II device.