Clearance Summary
ACA(R) BETA-2-MICROGLOBULIN (B2M) TEST PACK received FDA 510(k) clearance under submission number K914226, sponsored by E.I. Dupont DE Nemours & Co., Inc.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Ear, Nose, Throat review panel. The statutory decision date of record is 1991-11-19.
- Submission: K914226
- Applicant / Sponsor: E.I. Dupont DE Nemours & Co., Inc.
- Clearance pathway: Traditional
- Review panel: Ear, Nose, Throat
- Device class: Class I
- Regulation citation: 21 CFR 874.4420
- Decision date: 1991-11-19
Classification & Regulation
This clearance is catalogued under FDA product code JZB and 21 CFR 874.4420, within the Ear, Nose, Throat review panel as a Class I device.