Clearance Summary
ELITECH CLINICAL SYSTEMS PHOSPHORUS, URIC ACID MONO SL AND UREA UV SL REAGENTS received FDA 510(k) clearance under submission number K100263, sponsored by Seppim S.A.S.. 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 2011-05-06.
- Submission: K100263
- Applicant / Sponsor: Seppim S.A.S.
- Clearance pathway: Traditional
- Review panel: Clinical Chemistry
- Device class: Class I
- Regulation citation: 21 CFR 862.1580
- Decision date: 2011-05-06
Classification & Regulation
This clearance is catalogued under FDA product code CEO and 21 CFR 862.1580, within the Clinical Chemistry review panel as a Class I device.