Clearance Summary
TURBOX received FDA 510(k) clearance under submission number K873401, sponsored by Unipath , Ltd.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Immunology review panel. The statutory decision date of record is 1987-09-23.
- Submission: K873401
- Applicant / Sponsor: Unipath , Ltd.
- Clearance pathway: Traditional
- Review panel: Immunology
- Device class: Class I
- Regulation citation: 21 CFR 866.4540
- Decision date: 1987-09-23
Classification & Regulation
This clearance is catalogued under FDA product code JZW and 21 CFR 866.4540, within the Immunology review panel as a Class I device.