Clearance Summary
Immunalysis Opiates Urine Enzyme Immunoassay, Immunalysis Opiates Urine Calibrators 300, Immunalysis Opiates Urine Calibrators 2000, Immunalysis Multi-Drug Controls received FDA 510(k) clearance under submission number K143502, sponsored by Immunalysis Corporation. 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 2015-05-20.
- Submission: K143502
- Applicant / Sponsor: Immunalysis Corporation
- Clearance pathway: Traditional
- Review panel: Clinical Toxicology
- Device class: Class II
- Regulation citation: 21 CFR 862.3650
- Decision date: 2015-05-20
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.