Clearance Summary
OPIATE ORAL FLUID HOMOGENEOUS ENZYME IMMUNOASSAY, CALIBRATORS AND CONTROLS received FDA 510(k) clearance under submission number K050988, sponsored by Lin-Zhi International, Inc.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Clinical Chemistry review panel. The statutory decision date of record is 2006-04-06.
- Submission: K050988
- Applicant / Sponsor: Lin-Zhi International, Inc.
- Clearance pathway: Traditional
- Review panel: Clinical Chemistry
- Device class: Class I
- Regulation citation: 21 CFR 862.2250
- Decision date: 2006-04-06
Classification & Regulation
This clearance is catalogued under FDA product code DLG and 21 CFR 862.2250, within the Clinical Chemistry review panel as a Class I device.