Clearance Summary
UNILET LANCET received FDA 510(k) clearance under submission number K842517, sponsored by Ulster Scientific, Inc.. 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 1984-09-20.
- Submission: K842517
- Applicant / Sponsor: Ulster Scientific, Inc.
- Clearance pathway: Traditional
- Review panel: General Hospital
- Device class: Class I
- Regulation citation: 21 CFR 880.6140
- Decision date: 1984-09-20
Classification & Regulation
This clearance is catalogued under FDA product code FML and 21 CFR 880.6140, within the General Hospital review panel as a Class I device.