510(k) K231988 · JWY Manual Antimicrobial Susceptibility Test Systems
Sensititre 20-24-hour Haemophilus influenzae/Streptococcus pneumoniae MIC or Breakpoint Susceptibility System with Dalbavancin in the dilution range of 0.0005-2µg/ml
| Applicant | Thermo Fisher Scientific, Oakwood Village OH, US |
| Decision | Substantially Equivalent, Aug 30, 2023 |
| Received | Jul 5, 2023 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K231988
No recall in the FDA data names this 510(k).
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