K193024

Substantially Equivalent

Sensititre 20-24 hour Haemophilus influenzae/Streptococcus pneumoniae MIC or Breakpoint, Susceptibility System with Lefamulin in the dilution range of 0.008-16ug/mL

Applicant: Thermo Fisher Scientific
Product code: JWY
Advisory panel: Microbiology
Date received: 2019-10-30
Decision date: 2020-01-08
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Oakwood Village, OH, US

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