Clearance Summary
SCRIPPSYSTEM C3 RID KIT received FDA 510(k) clearance under submission number K810501, sponsored by Scripps-Miles, 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: K810501
- Applicant / Sponsor: Scripps-Miles, Inc.
- Clearance pathway: Traditional
- Review panel: Immunology
- Device class: Class II
- Regulation citation: 21 CFR 866.5240
- Decision date: 1981-04-08
Classification & Regulation
This clearance is catalogued under FDA product code CZW and 21 CFR 866.5240, within the Immunology review panel as a Class II device.