Clearance Summary
AEGIS I.V. STRIPS received FDA 510(k) clearance under submission number K812080, sponsored by Warner-Lambert Co.. The device was reviewed via the Traditional premarket notification pathway and assigned to the General Hospital review panel. The statutory decision date of record is 1981-08-03.
- Submission: K812080
- Applicant / Sponsor: Warner-Lambert Co.
- Clearance pathway: Traditional
- Review panel: General Hospital
- Device class: Class I
- Regulation citation: 21 CFR 880.5210
- Decision date: 1981-08-03
Classification & Regulation
This clearance is catalogued under FDA product code KMK and 21 CFR 880.5210, within the General Hospital review panel as a Class I device.