Clearance Summary
HUMAN IGG SUBCLASSES ELISA COMBI KIT received FDA 510(k) clearance under submission number K943098, sponsored by Research Diagnostics, 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 1994-09-07.
- Submission: K943098
- Applicant / Sponsor: Research Diagnostics, Inc.
- Clearance pathway: Traditional
- Review panel: Immunology
- Device class: Class I
- Regulation citation: 21 CFR 866.5530
- Decision date: 1994-09-07
Classification & Regulation
This clearance is catalogued under FDA product code DAS and 21 CFR 866.5530, within the Immunology review panel as a Class I device.