K241967

Substantially Equivalent

The Sensititre 20 - 24 hour Haemophilus influenzae/Streptococcus pneumoniae (HP) MIC or Breakpoint Susceptibility System with ceftriaxone in the dilution range of 0.015 - 2 ug/ml.

Applicant: Thermo Fisher Scientific
Product code: JWY
Advisory panel: Microbiology
Date received: 2024-07-03
Decision date: 2024-10-01
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Oakwood Village, OH, US

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