Name: Predicase
Price: 199 USD

K-number	K183033
Device name	Sensititre 18-24 hour MIC or Breakpoint Susceptibility System with Omadacycline in the dilution range of 0.03-32ug/ml
Applicant	Thermo Fisher Scientific
Product code	JWY
Device class	Class II
Decision date	Jan 4, 2019
Decision	Substantially Equivalent
Regulation	866.1640

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Source

View the full FDA submission: accessdata.fda.gov

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Sensititre 18-24 hour MIC or Breakpoint Susceptibility System with Omadacycline in the dilution range of 0.03-32ug/ml

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