Clearance Summary
N-ACETYLPROCAINAMIDE CALIBRATOR received FDA 510(k) clearance under submission number K833385, 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 1983-12-16.
- Submission: K833385
- Applicant / Sponsor: E.I. Dupont DE Nemours & Co., Inc.
- Clearance pathway: Traditional
- Review panel: Clinical Chemistry
- Device class: Class I
- Regulation citation: 21 CFR 862.2250
- Decision date: 1983-12-16
Classification & Regulation
This clearance is catalogued under FDA product code DLG and 21 CFR 862.2250, within the Clinical Chemistry review panel as a Class I device.