bioMerieux, Inc. · Class II · Cleared Jan 27, 2023
| K-number | K220803 |
| Device name | VITEK 2 AST-Gram Positive Moxifloxacin (=0.25 - =8 µg/ml), VITEK 2 AST-GP Moxifloxacin (=0.25 - =8 µg/mL), VITEK 2 AST-GP Moxifloxacin |
| Applicant | bioMerieux, Inc. |
| Product code | LON |
| Device class | Class II |
| Decision date | Jan 27, 2023 |
| Decision | Substantially Equivalent |
| Regulation | 866.1645 |
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