Name: Predicase
Price: 199 USD

K-number	K974171
Device name	COPAXONE (GLATIRAMER ACETATE FOR INJECTION) EZ-JECT FROM SHARED SOLUTIONS
Applicant	Teva Medical, Ltd.
Product code	KZH
Device class	Class II
Decision date	Dec 19, 1997
Decision	Substantially Equivalent
Regulation	880.6920

AI Summary

AI extraction for this record is queued and will appear within 24 hours. View full FDA record →

Source

View the full FDA submission: accessdata.fda.gov

Researching this as a predicate?

Want a transparent AI-ranking score, AI-discovered related predicates, ongoing safety and warning-letter monitoring, full predicate chain lineage, and a drafted SE rationale — all saved to your own project? That's what an account adds.

Start free trial →

COPAXONE (GLATIRAMER ACETATE FOR INJECTION) EZ-JECT FROM SHARED SOLUTIONS

Everything you need for a 510(k) submission. Nothing you don't.