Clearance Summary
ENZYMATIC CHOLESTEROL (COLORIMETRIC received FDA 510(k) clearance under submission number K823784, sponsored by Analytical & Research Chemicals, 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 1983-01-14.
- Submission: K823784
- Applicant / Sponsor: Analytical & Research Chemicals, Inc.
- Clearance pathway: Traditional
- Review panel: Clinical Chemistry
- Device class: Class I
- Regulation citation: 21 CFR 862.1175
- Decision date: 1983-01-14
Classification & Regulation
This clearance is catalogued under FDA product code CHH and 21 CFR 862.1175, within the Clinical Chemistry review panel as a Class I device.