Clearance Summary
ONTRAK TESTSTIK 3 FOR COCAINE/MORPHINE/THC,CAT. 1118595 received FDA 510(k) clearance under submission number K994165, sponsored by Roche Diagnostics Corp.. 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 2000-04-07.
- Submission: K994165
- Applicant / Sponsor: Roche Diagnostics Corp.
- Clearance pathway: Traditional
- Review panel: Clinical Toxicology
- Device class: Class II
- Regulation citation: 21 CFR 862.3250
- Decision date: 2000-04-07
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.