Clearance Summary
ACA PHOSPHORUS ANALYTICAL TEST PACK received FDA 510(k) clearance under submission number K760634, 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 1976-11-24.
- Submission: K760634
- Applicant / Sponsor: E.I. Dupont DE Nemours & Co., Inc.
- Clearance pathway: Traditional
- Review panel: Clinical Chemistry
- Device class: Class I
- Regulation citation: 21 CFR 862.1580
- Decision date: 1976-11-24
Classification & Regulation
This clearance is catalogued under FDA product code CEO and 21 CFR 862.1580, within the Clinical Chemistry review panel as a Class I device.