COPAXONE (GLATIRAMER ACETATE FOR INJECTION) EZ-JECT FROM SHARED SOLUTIONS— 510(k) K974171
Substantially EquivalentTeva Medical, Ltd.
FDA 510(k) clearance K974171 for COPAXONE (GLATIRAMER ACETATE FOR INJECTION) EZ-JECT FROM SHARED SOLUTIONS, Substantially Equivalent on 1997-12-19. Applicant: Teva Medical, Ltd..
Clearance details
- Applicant
- Teva Medical, Ltd.
- Product code
- Code KZH
- Advisory panel
- General Hospital
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Kulpsville, PA, US
Adverse events under product code KZH
product code KZH- Other
- 1
- Total
- 1
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Data sourced from openFDA. This site is unofficial and independent of the FDA.