Clearance Summary
STANBIO ACETAMINOPHEN TEST SET #0850 received FDA 510(k) clearance under submission number K801014, sponsored by Stanbio Laboratory. 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 1980-06-20.
- Submission: K801014
- Applicant / Sponsor: Stanbio Laboratory
- Clearance pathway: Traditional
- Review panel: Clinical Toxicology
- Device class: Class II
- Regulation citation: 21 CFR 862.3030
- Decision date: 1980-06-20
Classification & Regulation
This clearance is catalogued under FDA product code LDP and 21 CFR 862.3030, within the Clinical Toxicology review panel as a Class II device.