Clearance Summary
AT HOME DRUG TEST, MODEL 9073 T received FDA 510(k) clearance under submission number K010650, sponsored by Phamatech. 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 2001-03-30.
- Submission: K010650
- Applicant / Sponsor: Phamatech
- Clearance pathway: Special
- Review panel: Clinical Toxicology
- Device class: Class II
- Regulation citation: 21 CFR 862.3250
- Decision date: 2001-03-30
Classification & Regulation
This clearance is catalogued under FDA product code DIO and 21 CFR 862.3250, within the Clinical Toxicology review panel as a Class II device.