DeviceClearance

Sensititre 18 - 24 hour MIC or Breakpoint Susceptibility System with Dalbavancin (0.0005 - 2ug/mL)— 510(k) K150236

Substantially Equivalent

Thermo Fisher Scientific

FDA 510(k) clearance K150236 for Sensititre 18 - 24 hour MIC or Breakpoint Susceptibility System with Dalbavancin (0.0005 - 2ug/mL), Substantially Equivalent on 2015-07-27. Applicant: Thermo Fisher Scientific.

Clearance details

Applicant
Thermo Fisher Scientific
Product code
Code JWY
Advisory panel
Microbiology
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Oakwood Village, OH, US
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Data sourced from openFDA. This site is unofficial and independent of the FDA.