Clearance Summary
ACA CHOLESEROL/HDL CHOLESTEROL CALIBRAT. received FDA 510(k) clearance under submission number K800206, 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 1980-03-03.
- Submission: K800206
- Applicant / Sponsor: E.I. Dupont DE Nemours & Co., Inc.
- Clearance pathway: Traditional
- Review panel: Clinical Chemistry
- Device class: Class II
- Regulation citation: 21 CFR 862.1150
- Decision date: 1980-03-03
Classification & Regulation
This clearance is catalogued under FDA product code JIS and 21 CFR 862.1150, within the Clinical Chemistry review panel as a Class II device.