| K-number | K040845 |
| Device name | VITEK 2 ESBL TEST |
| Applicant | bioMerieux, Inc. |
| Product code | LON |
| Device class | Class II |
| Decision date | Jun 8, 2004 |
| Decision | Substantially Equivalent |
| Regulation | 866.1645 |
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