Medical Device Manufacturer · AU , Noble Park

Thermo Fisher Scientific - FDA 510(k) Cleared Devices

64 submissions · 64 cleared · Since 2007
64
Total
64
Cleared
0
Denied

FDA 510(k) cleared devices by Thermo Fisher Scientific Microbiology

57 devices
1-12 of 57
Cleared Sep 25, 2025
The Sensititre 18-24 hour MIC or Breakpoint Susceptibility System with...
K252062 · JWY
Microbiology · 86d
Cleared Sep 05, 2025
The Sensititre 18 - 24 hour MIC or Breakpoint Susceptibility System with...
K250575 · JWY
Microbiology · 191d
Cleared Aug 28, 2025
The Sensititre 18-24 hour MIC or Breakpoint Susceptibility System with...
K252014 · JWY
Microbiology · 62d
Cleared Jun 30, 2025
The Sensititre 18-24 hour MIC or Breakpoint Susceptibility System with...
K250990 · JWY
Microbiology · 91d
Cleared Jun 20, 2025
The Sensititre 20-24 hour Haemophilus influenzae/Streptococcus pneumoniae...
K242843 · JWY
Microbiology · 273d
Cleared May 22, 2025
The Sensititre 18-24 hour MIC or Breakpoint Susceptibility System with...
K242659 · JWY
Microbiology · 260d
Cleared Apr 15, 2025
The Sensititre 18-24 hour MIC or Breakpoint Susceptibility System with...
K242658 · JWY
Microbiology · 223d
Cleared Feb 27, 2025
The Sensititre YeastOne Susceptibility System with Micafungin in the dilution...
K243738 · NGZ
Microbiology · 85d
Cleared Feb 10, 2025
The Sensititre 20-24 hour Haemophilus influenzae/Streptococcus pneumoniae...
K242905 · JWY
Microbiology · 139d
Cleared Feb 10, 2025
The Sensititre 20-24 hour Haemophilus influenzae/Streptococcus pneumoniae...
K243201 · JWY
Microbiology · 132d
Cleared Dec 19, 2024
The Sensititre 18-24 hour MIC or Breakpoint Susceptibility System with...
K243169 · JWY
Microbiology · 80d
Cleared Dec 05, 2024
The Sensititre 18-24 hour MIC or Breakpoint Susceptibility System with...
K242653 · JWY
Microbiology · 92d

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