COPAXONE (GLATIRAMER ACETATE FOR INJECTION) EZ-JECT FROM SHARED SOLUTIONS— 510(k) K974171

Name: FDA 510(k) clearance K974171
Creator: U.S. Food and Drug Administration
Published: 1997-12-19

Substantially Equivalent

Teva 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.. Device class: 2.

Clearance details

Applicant: Teva Medical, Ltd.
Product code: Code KZH
Device class: Class 2
Regulation: 21 CFR 880.6920
Advisory panel: General Hospital
Date received: 1997-11-05
Decision date: 1997-12-19
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Kulpsville, PA, US

Download summary PDF View on FDA.gov ↗

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Adverse events under product code KZH

product code KZH

Other: 1
Total: 1

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. 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.