Clearance Summary
COPAXONE (GLATIRAMER ACETATE FOR INJECTION) EZ-JECT FROM SHARED SOLUTIONS received FDA 510(k) clearance under submission number K974171, sponsored by Teva Medical, Ltd.. The device was reviewed via the Traditional premarket notification pathway and assigned to the General Hospital review panel. The statutory decision date of record is 1997-12-19.
- Submission: K974171
- Applicant / Sponsor: Teva Medical, Ltd.
- Clearance pathway: Traditional
- Review panel: General Hospital
- Device class: Class II
- Regulation citation: 21 CFR 880.6920
- Decision date: 1997-12-19
Classification & Regulation
This clearance is catalogued under FDA product code KZH and 21 CFR 880.6920, within the General Hospital review panel as a Class II device.