Clearance Summary
Healgen® Accurate Oral Fluid Drug Test, Healgen® Accurate Oral Fluid Drug Test COT received FDA 510(k) clearance under submission number K223162, sponsored by Healgen Scientific,, LLC. 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 2023-03-17.
- Submission: K223162
- Applicant / Sponsor: Healgen Scientific,, LLC
- Clearance pathway: Traditional
- Review panel: Clinical Toxicology
- Device class: Class II
- Regulation citation: 21 CFR 862.3870
- Decision date: 2023-03-17
Classification & Regulation
This clearance is catalogued under FDA product code LDJ and 21 CFR 862.3870, within the Clinical Toxicology review panel as a Class II device.