Clearance Summary
CRP SLIDE received FDA 510(k) clearance under submission number K810862, 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 1981-04-08.
- Submission: K810862
- Applicant / Sponsor: Syn-Kit, Inc.
- Clearance pathway: Traditional
- Review panel: Immunology
- Device class: Class II
- Regulation citation: 21 CFR 866.5270
- Decision date: 1981-04-08
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.