Class Class II

The Sensititre 20 – 24 hour Haemophilus influenzae/Streptococcus pneumoniae (HP) MIC or Breakpoint Susceptibility System with Meropenem in the dilution range of 0.015 – 32 ug/ml. (K242021)

K242021 2024-10-09 Traditional
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Description

The Sensititre 20 - 24 hour Haemophilus influenzae/Streptococcus pneumoniae (HP) MIC or Breakpoint Susceptibility System with Meropenem in the dilution range of 0.015 - 32 ug/ml. by Thermo Fisher Scientific, an FDA 510(k) cleared microbiology device.

Regulatory Information

Device ClassClass Class II
510(k) NumberK242021
Clearance Date2024-10-09
Clearance TypeTraditional
Product CodeJWY
Regulation Number866.1640

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