Clearance Summary
ACA URINARY PROTEIN ANALYTICAL TEST PACK received FDA 510(k) clearance under submission number K822231, 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 1982-09-30.
- Submission: K822231
- Applicant / Sponsor: E.I. Dupont DE Nemours & Co., Inc.
- Clearance pathway: Traditional
- Review panel: Clinical Chemistry
- Device class: Class II
- Regulation citation: 21 CFR 862.1635
- Decision date: 1982-09-30
Classification & Regulation
This clearance is catalogued under FDA product code JGQ and 21 CFR 862.1635, within the Clinical Chemistry review panel as a Class II device.