Clearance Summary
URINE COCAINE METABOLITE SCREEN FLEX REAGENT CARTRIDGE, CATALOG# DF92A received FDA 510(k) clearance under submission number K033713, sponsored by Dade Behring, Inc.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Clinical Toxicology review panel. The statutory decision date of record is 2004-02-09.
- Submission: K033713
- Applicant / Sponsor: Dade Behring, Inc.
- Clearance pathway: Traditional
- Review panel: Clinical Toxicology
- Device class: Class II
- Regulation citation: 21 CFR 862.3250
- Decision date: 2004-02-09
Classification & Regulation
This clearance is catalogued under FDA product code DIO and 21 CFR 862.3250, within the Clinical Toxicology review panel as a Class II device.