Name: Predicase
Price: 199 USD

K-number	K202612
Device name	Sensititre 20-24 hour Haemophilus influenzae /Streptococcus pneumoniae MIC or Breakpoint Susceptibility System with Dtest (containing erythromycin at 1 ug/mL and clindamycin at 0.5 ug/mL)
Applicant	Thermo Fisher Scientific
Product code	JWY
Device class	Class II
Decision date	Jul 23, 2021
Decision	Substantially Equivalent
Regulation	866.1640

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Source

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 Dtest (containing erythromycin at 1 ug/mL and clindamycin at 0.5 ug/mL)

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