Clearance Summary
SERIM DIALYSATE MONITOR TEST STRIP received FDA 510(k) clearance under submission number K043031, sponsored by Serim Research Corp.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Gastroenterology, Urology review panel. The statutory decision date of record is 2005-06-13.
- Submission: K043031
- Applicant / Sponsor: Serim Research Corp.
- Clearance pathway: Traditional
- Review panel: Gastroenterology, Urology
- Device class: Class II
- Regulation citation: 21 CFR 876.5820
- Decision date: 2005-06-13
Classification & Regulation
This clearance is catalogued under FDA product code NTZ and 21 CFR 876.5820, within the Gastroenterology, Urology review panel as a Class II device.