Name: Predicase
Price: 199 USD

K-number	K230935
Device name	Sensititre 20-24 hour Haemophilus influenzae/Streptococcus pneumoniae MIC, or Breakpoint Susceptibility System with Imipenem-relebactam in the dilution, range of 0.03/4-128-4ug/ml (Haemophilus influenzae)
Applicant	Thermo Fisher Scientific
Product code	JWY
Device class	Class II
Decision date	Jun 30, 2023
Decision	Substantially Equivalent
Regulation	866.1640

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Sensititre 20-24 hour Haemophilus influenzae/Streptococcus pneumoniae MIC, or Breakpoint Susceptibility System with Imipenem-relebactam in the dilution, range of 0.03/4-128-4ug/ml (Haemophilus influenzae)

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