Clearance Summary
V-TREND EIA T4 ENZYME IMMUNOASSAY TEST KIT received FDA 510(k) clearance under submission number K854971, sponsored by V-Tech, 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 1986-02-06.
- Submission: K854971
- Applicant / Sponsor: V-Tech, Inc.
- Clearance pathway: Traditional
- Review panel: Clinical Chemistry
- Device class: Class II
- Regulation citation: 21 CFR 862.1700
- Decision date: 1986-02-06
Classification & Regulation
This clearance is catalogued under FDA product code KLI and 21 CFR 862.1700, within the Clinical Chemistry review panel as a Class II device.