K181946

Substantially Equivalent

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
Advisory panel: Microbiology
Date received: 2018-07-20
Decision date: 2018-08-08
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Oakwood Village, OH, US

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