Clearance Summary
THROMBELASTOGRAPH COAGULATION ANALYZER TEG-5000 SERIES received FDA 510(k) clearance under submission number K002177, sponsored by Haemoscope Corp.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Hematology review panel. The statutory decision date of record is 2000-09-14.
- Submission: K002177
- Applicant / Sponsor: Haemoscope Corp.
- Clearance pathway: Traditional
- Review panel: Hematology
- Device class: Class II
- Regulation citation: 21 CFR 864.5425
- Decision date: 2000-09-14
Classification & Regulation
This clearance is catalogued under FDA product code JPA and 21 CFR 864.5425, within the Hematology review panel as a Class II device.