Class Class II

The Sensititre 18-24 hour MIC or Breakpoint Susceptibility System with Amikacin in the dilution range of 0.25-256 ug/mL (K252014)

K252014 2025-08-28 Traditional
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Description

The Sensititre 18-24 hour MIC or Breakpoint Susceptibility System with Amikacin in the dilution range of 0.25-256 ug/mL by Thermo Fisher Scientific, an FDA 510(k) cleared microbiology device.

Regulatory Information

Device ClassClass Class II
510(k) NumberK252014
Clearance Date2025-08-28
Clearance TypeTraditional
Product CodeJWY
Regulation Number866.1640

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