Clearance Summary
SCRIPPSYSTEM RHEUMATOID FACTOR LATEX KIT received FDA 510(k) clearance under submission number K810141, 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 1981-02-09.
- Submission: K810141
- Applicant / Sponsor: Scripps-Miles, Inc.
- Clearance pathway: Traditional
- Review panel: Immunology
- Device class: Class II
- Regulation citation: 21 CFR 866.5775
- Decision date: 1981-02-09
Classification & Regulation
This clearance is catalogued under FDA product code DHR and 21 CFR 866.5775, within the Immunology review panel as a Class II device.