Name: Predicase
Price: 199 USD

K-number	K150236
Device name	Sensititre 18 - 24 hour MIC or Breakpoint Susceptibility System with Dalbavancin (0.0005 - 2ug/mL)
Applicant	Thermo Fisher Scientific
Product code	JWY
Device class	Class II
Decision date	Jul 27, 2015
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 Dalbavancin (0.0005 - 2ug/mL)

Everything you need for a 510(k) submission. Nothing you don't.