Clearance Summary
COPAXONE (COPOLYMER-1 FOR INJECTION) SELF-INJECTION ADMINISTRATION PACKAGE received FDA 510(k) clearance under submission number K964060, sponsored by Travenol Laboratories (Israel) , 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 1996-12-24.
- Submission: K964060
- Applicant / Sponsor: Travenol Laboratories (Israel) , Ltd.
- Clearance pathway: Traditional
- Review panel: General Hospital
- Device class: Class II
- Regulation citation: 21 CFR 880.5860
- Decision date: 1996-12-24
Classification & Regulation
This clearance is catalogued under FDA product code FMF and 21 CFR 880.5860, within the General Hospital review panel as a Class II device.