Thermo Fisher Scientific - FDA 510(k) Cleared Devices
64
Total
64
Cleared
0
Denied
57 devices
Cleared
Dec 15, 2021
Sensititre YeastOne Susceptibility System with Voriconazole in the dilution...
Microbiology
211d
Cleared
Jul 23, 2021
Sensititre 20-24 hour Haemophilus influenzae /Streptococcus pneumoniae MIC or...
Microbiology
317d
Cleared
Mar 12, 2020
Sensititre 18-24 hour MIC or Breakpoint Susceptibility System with...
Microbiology
83d
Cleared
Jan 08, 2020
Sensititre 20-24 hour Haemophilus influenzae/Streptococcus pneumoniae MIC or...
Microbiology
70d
Cleared
Nov 06, 2019
Thermo Scientific Sensititre ARIS HiQ System
Microbiology
112d
Cleared
Nov 06, 2019
Thermo Scientific Sensititre ARIS HiQ System
Microbiology
111d
Cleared
Nov 06, 2019
Sensititre 18-24 Hour MIC or Breakpoint Susceptibility System with Lefamulin...
Microbiology
40d
Cleared
Oct 16, 2019
Sensititre 18-24 hour MIC or Breakpoint Susceptibility System with...
Microbiology
58d
Cleared
Feb 15, 2019
Sensititre 20-24 hour Haemophilus influenzae/Streptococcus pneumoniae MIC or...
Microbiology
77d
Cleared
Jan 04, 2019
Sensititre 18-24 hour MIC or Breakpoint Susceptibility System with...
Microbiology
64d
Cleared
Nov 30, 2018
Sensititre 18-24 hour MIC or Breakpoint Susceptibility System with...
Microbiology
60d
Cleared
Aug 08, 2018
Sensititre 18-24 hour MIC Breakpoint Susceptibility System with Plazomicin in...
Microbiology
19d
Cleared
Dec 01, 2017
Sensititre 18-24 hour MIC or Breakpoint Susceptibility System with...
Microbiology
60d
Cleared
Oct 13, 2017
Sensititre 18-24 hour MIC or Breakpoint Susceptibility System with...
Microbiology
60d
Cleared
Aug 30, 2017
The Sensititre 20-24 hour Haemophilus influenzae/Streptococcus pneumoniae MIC...
Microbiology
33d
Cleared
Aug 01, 2017
The Sensititre 18-24 hour MIC or Breakpoint Susceptibility System with...
Microbiology
40d
Cleared
Dec 21, 2015
The Sensititre 18-24 hour MIC or Breakpoint Susceptibility System with...
Microbiology
87d
Cleared
Aug 28, 2015
Sensititre 18-24 hours MIC or BP Susceptibility System with...
Microbiology
177d
Cleared
Jul 27, 2015
Sensititre 18 - 24 hour MIC or Breakpoint Susceptibility System with...
Microbiology
175d
Cleared
Apr 01, 2015
Sensititre Susceptibility plates
Microbiology
135d
Cleared
Mar 05, 2015
The Sensititre HP MIC Susceptibility plate with Oritavancin (0.0005-8mcg/ml)
Microbiology
83d
Cleared
Mar 02, 2015
Sensititre HP MIC Susceptibility Plate with Tedizolid (0.002-4 mcg/ml)
Microbiology
193d
Cleared
Feb 19, 2015
Sensititre Susceptibility Plates
Microbiology
86d
Cleared
Dec 23, 2014
SENSITITRE 18-24 HOUR SUSCEPTIBILITY PLATES
Microbiology
139d
Cleared
Oct 21, 2014
SENSITITRE SUSCEPTIBILITY PLATES
Microbiology
123d