Clearance Summary
TRAX(TM) CD4 TEST KIT received FDA 510(k) clearance under submission number K925255, sponsored by T Cell Diagnostics, Inc.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Hematology review panel. The statutory decision date of record is 1995-05-15.
- Submission: K925255
- Applicant / Sponsor: T Cell Diagnostics, Inc.
- Clearance pathway: Traditional
- Review panel: Hematology
- Device class: Class II
- Regulation citation: 21 CFR 864.5220
- Decision date: 1995-05-15
Classification & Regulation
This clearance is catalogued under FDA product code GKZ and 21 CFR 864.5220, within the Hematology review panel as a Class II device.