Thermo Fisher Scientific · Class II · Cleared Oct 31, 2023
| K-number | K232310 |
| Device name | Sensititre 20-24 hour Haemophilus influenzaelStreptococcus pneumoniae MIC or Breakpoint Susceptibility System with Ceftolozane-tazobactam in the dilution range of 0.03/4-64/4ug/ml |
| Applicant | Thermo Fisher Scientific |
| Product code | JWY |
| Device class | Class II |
| Decision date | Oct 31, 2023 |
| Decision | Substantially Equivalent |
| Regulation | 866.1640 |
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