Clearance Summary
URITEST 9, INLAB REAGENT STRIPS URINALY received FDA 510(k) clearance under submission number K822709, sponsored by Laprol Scientific, 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 1983-01-28.
- Submission: K822709
- Applicant / Sponsor: Laprol Scientific, Inc.
- Clearance pathway: Traditional
- Review panel: Clinical Chemistry
- Device class: Class I
- Regulation citation: 21 CFR 862.1095
- Decision date: 1983-01-28
Classification & Regulation
This clearance is catalogued under FDA product code JMA and 21 CFR 862.1095, within the Clinical Chemistry review panel as a Class I device.