Clearance Summary
DUPONT ACALACTIC ACID (LA) TEST received FDA 510(k) clearance under submission number K802064, 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 1980-09-26.
- Submission: K802064
- Applicant / Sponsor: E.I. Dupont DE Nemours & Co., Inc.
- Clearance pathway: Traditional
- Review panel: Clinical Chemistry
- Device class: Class I
- Regulation citation: 21 CFR 862.1450
- Decision date: 1980-09-26
Classification & Regulation
This clearance is catalogued under FDA product code KHP and 21 CFR 862.1450, within the Clinical Chemistry review panel as a Class I device.