Clearance Summary
K-SHIELD Zen (Model Numbers: PBMH/ PBMA/ PBM) received FDA 510(k) clearance under submission number K230408, sponsored by Sb-Kawasumi Laboratories, Inc.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Clinical Chemistry review panel. The statutory decision date of record is 2023-06-01.
- Submission: K230408
- Applicant / Sponsor: Sb-Kawasumi Laboratories, Inc.
- Clearance pathway: Traditional
- Review panel: Clinical Chemistry
- Device class: Class II
- Regulation citation: 21 CFR 862.1675
- Decision date: 2023-06-01
Classification & Regulation
This clearance is catalogued under FDA product code JKA and 21 CFR 862.1675, within the Clinical Chemistry review panel as a Class II device.