The Sensititre 20-24 hour Haemophilus influenzae/Streptococcus pneumoniae (HP) MIC or Breakpoint Susceptibility System with Ceftobiprole in the dilution range of 0.008-16 ug/mL.— 510(k) K242843

Substantially Equivalent

Thermo Fisher Scientific

FDA 510(k) clearance K242843 for The Sensititre 20-24 hour Haemophilus influenzae/Streptococcus pneumoniae (HP) MIC or Breakpoint Susceptibility System with Ceftobiprole in the dilution range of 0.008-16 ug/mL., Substantially Equivalent on 2025-06-20. Applicant: Thermo Fisher Scientific.

Clearance details

Applicant: Thermo Fisher Scientific
Product code: Code JWY
Advisory panel: Microbiology
Date received: 2024-09-20
Decision date: 2025-06-20
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Oakwood Village, OH, US

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