Clearance Summary
UB ANALYZER, MODEL UA-1/REAGENT KIT/BILIRUBIN CON. received FDA 510(k) clearance under submission number K871115, sponsored by Labo Science-USA, Inc.. 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 1989-01-27.
- Submission: K871115
- Applicant / Sponsor: Labo Science-USA, Inc.
- Clearance pathway: Traditional
- Review panel: Clinical Chemistry
- Device class: Class II
- Regulation citation: 21 CFR 862.1110
- Decision date: 1989-01-27
Classification & Regulation
This clearance is catalogued under FDA product code CIG and 21 CFR 862.1110, within the Clinical Chemistry review panel as a Class II device.