Name: Predicase
Price: 199 USD

K-number	K223844
Device name	Sensititre 20-24-hour Haemophilus influenzae/Streptococcus pneumoniae MIC or Breakpoint Susceptibility System with Delafloxacin in the dilution range of 0.00025-8ug/ml (Streptococcus species) and 0.000125-8ug/ml (Haemophilus influenzae)
Applicant	Thermo Fisher Scientific
Product code	JWY
Device class	Class II
Decision date	Mar 21, 2023
Decision	Substantially Equivalent
Regulation	866.1640

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View the full FDA submission: accessdata.fda.gov

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Sensititre 20-24-hour Haemophilus influenzae/Streptococcus pneumoniae MIC or Breakpoint Susceptibility System with Delafloxacin in the dilution range of 0.00025-8ug/ml (Streptococcus species) and 0.000125-8ug/ml (Haemophilus influenzae)

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