Thermo Fisher Scientific · Class II · Cleared Dec 21, 2015
| K-number | K152774 |
| Device name | The Sensititre 18-24 hour MIC or Breakpoint Susceptibility System with Ceftazidime/Avibactam in the dilutions range of 0.015/4 - 32/4 ug/mL |
| Applicant | Thermo Fisher Scientific |
| Product code | JWY |
| Device class | Class II |
| Decision date | Dec 21, 2015 |
| Decision | Substantially Equivalent |
| Regulation | 866.1640 |
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