Beckman Coulter, Inc. · Class II · Cleared Feb 12, 2019
| K-number | K183127 |
| Device name | MicroScan Dried Gram Negative MIC/Combo Panels with Meropenem/Vaborbactam (0.03/8-64/8ug/mL) |
| Applicant | Beckman Coulter, Inc. |
| Product code | LTT |
| Device class | Class II |
| Decision date | Feb 12, 2019 |
| Decision | Substantially Equivalent |
| Regulation | 866.1640 |
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