Clearance Summary
EMIT II PLUS OPIATE ASSAY, MODEL OSR9B229 received FDA 510(k) clearance under submission number K011289, sponsored by Syva Co., Dade Behring, Inc.. The device was reviewed via the Special premarket notification pathway and assigned to the Clinical Toxicology review panel. The statutory decision date of record is 2001-05-15.
- Submission: K011289
- Applicant / Sponsor: Syva Co., Dade Behring, Inc.
- Clearance pathway: Special
- Review panel: Clinical Toxicology
- Device class: Class II
- Regulation citation: 21 CFR 862.3650
- Decision date: 2001-05-15
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.