bioMerieux, Inc. · Class II · Cleared Sep 28, 2020
| K-number | K193299 |
| Device name | VITEK 2 AST-Gram Negative Ceftazidime (=<0.5 - =>32 µg/mL) |
| Applicant | bioMerieux, Inc. |
| Product code | LON |
| Device class | Class II |
| Decision date | Sep 28, 2020 |
| 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