DeviceClearance

Sensititre 20-24 hour Haemophilus influenzae/Streptococcus pneumoniae MIC or Breakpoint, Susceptibility System with Lefamulin in the dilution range of 0.008-16ug/mL— 510(k) K193024

Substantially Equivalent

Thermo Fisher Scientific

FDA 510(k) clearance K193024 for Sensititre 20-24 hour Haemophilus influenzae/Streptococcus pneumoniae MIC or Breakpoint, Susceptibility System with Lefamulin in the dilution range of 0.008-16ug/mL, Substantially Equivalent on 2020-01-08. Applicant: Thermo Fisher Scientific.

Clearance details

Applicant
Thermo Fisher Scientific
Product code
Code JWY
Advisory panel
Microbiology
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Oakwood Village, OH, US
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