Clearance Summary
ACA(R) BETA-2-MICROGLOBULIN CALIBRATOR received FDA 510(k) clearance under submission number K914225, sponsored by E.I. Dupont DE Nemours & Co., 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 1991-11-22.
- Submission: K914225
- Applicant / Sponsor: E.I. Dupont DE Nemours & Co., Inc.
- Clearance pathway: Traditional
- Review panel: Immunology
- Device class: Class II
- Regulation citation: 21 CFR 866.5630
- Decision date: 1991-11-22
Classification & Regulation
This clearance is catalogued under FDA product code JZG and 21 CFR 866.5630, within the Immunology review panel as a Class II device.