Clearance Summary
CPR SLIDE EIKEN received FDA 510(k) clearance under submission number K854819, sponsored by Syn-Kit, Inc.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Immunology review panel. The statutory decision date of record is 1986-02-26.
- Submission: K854819
- Applicant / Sponsor: Syn-Kit, Inc.
- Clearance pathway: Traditional
- Review panel: Immunology
- Device class: Class II
- Regulation citation: 21 CFR 866.5270
- Decision date: 1986-02-26
Classification & Regulation
This clearance is catalogued under FDA product code DCN and 21 CFR 866.5270, within the Immunology review panel as a Class II device.