Clearance Summary
BIOCHECK TOTAL T4 ENZYME IMMUNOASSAY TEST KIT, MODEL BC-1007 received FDA 510(k) clearance under submission number K991432, sponsored by Biocheck, 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 1999-06-02.
- Submission: K991432
- Applicant / Sponsor: Biocheck, Inc.
- Clearance pathway: Traditional
- Review panel: Clinical Chemistry
- Device class: Class II
- Regulation citation: 21 CFR 862.1700
- Decision date: 1999-06-02
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.