Clearance Summary
DIMENSION(R) XL CLINICAL CHEMISTRY SYSTEM received FDA 510(k) clearance under submission number K944093, sponsored by E.I. Dupont DE Nemours & Co., Inc.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Clinical Chemistry review panel. The statutory decision date of record is 1994-11-10.
- Submission: K944093
- Applicant / Sponsor: E.I. Dupont DE Nemours & Co., Inc.
- Clearance pathway: Traditional
- Review panel: Clinical Chemistry
- Device class: Class I
- Regulation citation: 21 CFR 862.2160
- Decision date: 1994-11-10
Classification & Regulation
This clearance is catalogued under FDA product code JJE and 21 CFR 862.2160, within the Clinical Chemistry review panel as a Class I device.