Clearance Summary
TURBOX FIBRINOGEN received FDA 510(k) clearance under submission number K884179, sponsored by Unipath , Ltd.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Hematology review panel. The statutory decision date of record is 1988-12-20.
- Submission: K884179
- Applicant / Sponsor: Unipath , Ltd.
- Clearance pathway: Traditional
- Review panel: Hematology
- Device class: Class II
- Regulation citation: 21 CFR 864.7340
- Decision date: 1988-12-20
Classification & Regulation
This clearance is catalogued under FDA product code KQJ and 21 CFR 864.7340, within the Hematology review panel as a Class II device.