Class Class II

The Sensititre 18 – 24 hour MIC or Breakpoint Susceptibility System with Aztreonam/avibactam in the dilution range of 0.008/4 – 64/4 ug/mL (K250575)

K250575 2025-09-05 Traditional
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Description

The Sensititre 18 - 24 hour MIC or Breakpoint Susceptibility System with Aztreonam/avibactam in the dilution range of 0.008/4 - 64/4 ug/mL by Thermo Fisher Scientific, an FDA 510(k) cleared microbiology device.

Regulatory Information

Device ClassClass Class II
510(k) NumberK250575
Clearance Date2025-09-05
Clearance TypeTraditional
Product CodeJWY
Regulation Number866.1640

Categories

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