Clearance Summary
MODIFIED LABELING FOR ACA LIPASE ANALYTICAL TEST received FDA 510(k) clearance under submission number K901858, 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 1990-06-12.
- Submission: K901858
- Applicant / Sponsor: E.I. Dupont DE Nemours & Co., Inc.
- Clearance pathway: Traditional
- Review panel: Clinical Chemistry
- Device class: Class I
- Regulation citation: 21 CFR 862.1465
- Decision date: 1990-06-12
Classification & Regulation
This clearance is catalogued under FDA product code CET and 21 CFR 862.1465, within the Clinical Chemistry review panel as a Class I device.