FDA 510(k) Applications Submitted by Joel Mathew

FDA 510(k) Number Submission Date Device Name Applicant
K240445 02/15/2024 The Sensititre 20 - 24 hour Haemophilus influenzae/Streptococcus pneumoniae (HP) MIC or Breakpoint Susceptibility System with Imipenem in the dilution range of 0.015 - 4 ug/ml. Thermofisher Scientific
K250990 03/31/2025 The Sensititre 18-24 hour MIC or Breakpoint Susceptibility System with Ciprofloxacin in the dilution range of 0.002-64 ug/mL Thermofisher Scientific
K241967 07/03/2024 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. Thermofisher Scientific
K231988 07/05/2023 Sensititre 20-24-hour Haemophilus influenzae/Streptococcus pneumoniae MIC or Breakpoint Susceptibility System with Dalbavancin in the dilution range of 0.0005-2╡g/ml Thermo Fisher Scientific
K242021 07/11/2024 The Sensititre 20 - 24 hour Haemophilus influenzae/Streptococcus pneumoniae (HP) MIC or Breakpoint Susceptibility System with Meropenem in the dilution range of 0.015 - 32 ug/ml. Thermo Fisher Scientific
K242653 09/04/2024 The Sensititre 18-24 hour MIC or Breakpoint Susceptibility System with Linezolid in the dilution range of 0.25-32 ug/mL Thermofisher Scientific
K242658 09/04/2024 The Sensititre 18-24 hour MIC or Breakpoint Susceptibility System with Moxifloxacin in the dilution range of 0.008-16 ug/mL Thermofisher Scientific
K242659 09/04/2024 The Sensititre 18-24 hour MIC or Breakpoint Susceptibility System with Vancomycin in the dilution range of 0.25-128 ug/mL Thermofisher Scientific
K242843 09/20/2024 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. Thermofisher Scientific
K242905 09/24/2024 The Sensititre 20-24 hour Haemophilus influenzae/Streptococcus pneumoniae (HP) MIC or Breakpoint Susceptibility System with Linezolid in the dilution range of 0.12-32 ug/mL Thermofisher Scientific
K243169 09/30/2024 The Sensititre 18-24 hour MIC or Breakpoint Susceptibility System with Ceftobiprole in the dilution range of 0.008-16 ug/mL Thermofisher Scientific
K243201 10/01/2024 The Sensititre 20-24 hour Haemophilus influenzae/Streptococcus pneumoniae (HP) MIC or Breakpoint Susceptibility System with penicillin in the dilution range of 0.015-32 ug/mL Thermofisher Scientific
K243738 12/04/2024 The Sensititre YeastOne Susceptibility System with Micafungin in the dilution range of 0.008-16 ╡g/mL Thermo Fisher Scientific


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