Name: Predicase
Price: 199 USD

K-number	K182797
Device name	Sensititre 18-24 hour MIC or Breakpoint Susceptibility System with Eravacycline in the dilution range of 0.008- 16 µg/mL
Applicant	Thermo Fisher Scientific
Product code	JWY
Device class	Class II
Decision date	Nov 30, 2018
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 Eravacycline in the dilution range of 0.008- 16 µg/mL

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