Clearance Summary
T4 MICROWELL EIA (ENZYME IMMUNOASSAY0 received FDA 510(k) clearance under submission number K950588, sponsored by Biomerica, 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 1995-06-29.
- Submission: K950588
- Applicant / Sponsor: Biomerica, Inc.
- Clearance pathway: Traditional
- Review panel: Clinical Chemistry
- Device class: Class II
- Regulation citation: 21 CFR 862.1700
- Decision date: 1995-06-29
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.