Clearance Summary
SENTINEL AMMONIA ULTRA DIAGNOSTIC ASSAY received FDA 510(k) clearance under submission number K051114, sponsored by Sentinel Ch. Srl. 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 2005-11-25.
- Submission: K051114
- Applicant / Sponsor: Sentinel Ch. Srl
- Clearance pathway: Traditional
- Review panel: Clinical Chemistry
- Device class: Class I
- Regulation citation: 21 CFR 862.1065
- Decision date: 2005-11-25
Classification & Regulation
This clearance is catalogued under FDA product code JIF and 21 CFR 862.1065, within the Clinical Chemistry review panel as a Class I device.