Clearance Summary
URISTRIP REAGENT STRIPS TEST FOR PROTEIN, GLUCOSE, PH AND BLOOD received FDA 510(k) clearance under submission number K946116, sponsored by Chemtech Labs, 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 1995-03-21.
- Submission: K946116
- Applicant / Sponsor: Chemtech Labs, Inc.
- Clearance pathway: Traditional
- Review panel: Clinical Chemistry
- Device class: Class II
- Regulation citation: 21 CFR 862.1340
- Decision date: 1995-03-21
Classification & Regulation
This clearance is catalogued under FDA product code JIL and 21 CFR 862.1340, within the Clinical Chemistry review panel as a Class II device.