Name: Predicase
Price: 199 USD

K-number	K181946
Device name	Sensititre 18-24 hour MIC Breakpoint Susceptibility System with Plazomicin in the dilution range of 0.06-128 ug/mL
Applicant	Thermo Fisher Scientific
Product code	JWY
Device class	Class II
Decision date	Aug 8, 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 Breakpoint Susceptibility System with Plazomicin in the dilution range of 0.06-128 ug/mL

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