Clearance Summary
E.P.T. PLUS TM received FDA 510(k) clearance under submission number K831535, sponsored by Warner-Lambert Co.. 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 1983-06-30.
- Submission: K831535
- Applicant / Sponsor: Warner-Lambert Co.
- Clearance pathway: Traditional
- Review panel: Clinical Chemistry
- Device class: Class II
- Regulation citation: 21 CFR 862.1155
- Decision date: 1983-06-30
Classification & Regulation
This clearance is catalogued under FDA product code JHJ and 21 CFR 862.1155, within the Clinical Chemistry review panel as a Class II device.