Thermo Fisher Scientific - FDA 510(k) Cleared Devices
Recent clearances: The Sensititre 18-24 hour MIC or Breakpoint Susceptibility System with Colistin in the dilution range of 0.12-16 ug/mL, 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, The Sensititre 18-24 hour MIC or Breakpoint Susceptibility System with Amikacin in the dilution range of 0.25-256 ug/mL
64
Total
64
Cleared
0
Denied
FDA 510(k) Regulatory Record - Thermo Fisher Scientific Toxicology ✕
4 devices
Cleared
Jul 17, 2009
QMS LIDOCAINE CALIBRATORS, MODEL 0374678
Toxicology
44d
Cleared
Jan 14, 2009
DRI METHADONE METABOLITE (100/300) ASSAY, CALIBRATORS AND CONTROLS
Toxicology
243d
Cleared
Dec 19, 2008
CEDIA MYCOPHENOLIC ACID ASSAY, CALIBRATORS, MAS MYCOPHENOLIC ACID CONTROLS
Toxicology
247d
Cleared
Apr 30, 2008
MAS TOX CONTROL
Toxicology
110d