Euroimmun Us, Inc. · Class II · Cleared Aug 12, 2016
| K-number | K153308 |
| Device name | EUROIMMUN Anti-West Nile Virus ELISA (IgM) |
| Applicant | Euroimmun Us, Inc. |
| Product code | NOP |
| Device class | Class II |
| Decision date | Aug 12, 2016 |
| Decision | Substantially Equivalent |
| Regulation | 866.3940 |
AI extraction for this record is queued and will appear within 24 hours. View full FDA record →
View the full FDA submission: accessdata.fda.gov