Clearance Summary
METH. & CALI. FOR THE DIMENSION CLINI/CHEM. SYSTEM received FDA 510(k) clearance under submission number K863840, 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 1986-11-05.
- Submission: K863840
- 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: 1986-11-05
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.