Clearance Summary
RHEUMATOID FACTOR-RAPID CARD TEST #65114 received FDA 510(k) clearance under submission number K830832, sponsored by Emd Chemicals, 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 1983-04-18.
- Submission: K830832
- Applicant / Sponsor: Emd Chemicals, Inc.
- Clearance pathway: Traditional
- Review panel: Immunology
- Device class: Class II
- Regulation citation: 21 CFR 866.5775
- Decision date: 1983-04-18
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.