Clearance Summary
ENA-C-T TOTAL CHOLESTEROL TEST MODEL F 20000, (PHYSICIAN DIRECTED USE) received FDA 510(k) clearance under submission number K981181, sponsored by Actimed Laboratories, 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 1998-08-03.
- Submission: K981181
- Applicant / Sponsor: Actimed Laboratories, Inc.
- Clearance pathway: Traditional
- Review panel: Clinical Chemistry
- Device class: Class I
- Regulation citation: 21 CFR 862.1175
- Decision date: 1998-08-03
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.