Clearance Summary
RHEUMA-CHECK ENZYME IMMUNOASSAY TEST received FDA 510(k) clearance under submission number K871196, sponsored by Orion Diagnostica, 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 1987-05-06.
- Submission: K871196
- Applicant / Sponsor: Orion Diagnostica, Inc.
- Clearance pathway: Traditional
- Review panel: Immunology
- Device class: Class II
- Regulation citation: 21 CFR 866.5775
- Decision date: 1987-05-06
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.