bioMerieux, Inc. · Class II · Cleared Feb 1, 2017
| K-number | K163083 |
| Device name | VITEK 2 AST-GN Tobramycin (</=1->/= 16 ug/mL); VITEK 2 AST-Gram Negative Tobramycin (</=1->/=16 ug/mL) |
| Applicant | bioMerieux, Inc. |
| Product code | LON |
| Device class | Class II |
| Decision date | Feb 1, 2017 |
| Decision | Substantially Equivalent |
| Regulation | 866.1645 |
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