Clearance Summary
INSTANT-VIEW BUP/NBUP URINE TEST. INSTANT-VERDICT BUP/NBUP URINE TEST; INSTANT-CONFIRMATORY BUP/NBUP URINE TEST received FDA 510(k) clearance under submission number K060527, sponsored by Alfa Scientific Designs, Inc.. The device was reviewed via the Abbreviated premarket notification pathway and assigned to the Clinical Toxicology review panel. The statutory decision date of record is 2006-07-25.
- Submission: K060527
- Applicant / Sponsor: Alfa Scientific Designs, Inc.
- Clearance pathway: Abbreviated
- Review panel: Clinical Toxicology
- Device class: Class II
- Regulation citation: 21 CFR 862.3650
- Decision date: 2006-07-25
Classification & Regulation
This clearance is catalogued under FDA product code DJG and 21 CFR 862.3650, within the Clinical Toxicology review panel as a Class II device.