Clearance Summary
QUICKSTRIP ONE STEP OPIATES TEST received FDA 510(k) clearance under submission number K993490, sponsored by Syntron Bioresearch, 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 1999-10-29.
- Submission: K993490
- Applicant / Sponsor: Syntron Bioresearch, Inc.
- Clearance pathway: Traditional
- Review panel: Clinical Toxicology
- Device class: Class II
- Regulation citation: 21 CFR 862.3650
- Decision date: 1999-10-29
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.