Medical Device Manufacturer · AU , Noble Park

Thermo Fisher Scientific

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

Thermo Fisher Scientific — FDA 510(k) Submissions

Thermo Fisher Scientific has submitted 64 FDA 510(k) premarket notifications since 2007, of which 64 received clearance as substantially equivalent to a predicate device.

The company's most frequent device categories include Manual Antimicrobial Susceptibility Test Systems, Susceptibility Test Plate, Antifungal, Instrument For Auto Reader & Interpretation Of Overnight Suscept. Systems, Culture Media, Antimicrobial Susceptibility Test, Excluding Mueller Hinton Agar, Drug Mixture Control Materials . Use the specialty filter in the sidebar to narrow results.

64 devices
1–25 of 64
The Sensititre 18-24 hour MIC or Breakpoint Susceptibility System with Colistin in the dilution range of 0.12-16 ug/mL
K252062 · JWY Manual Antimicrobial... · Microbiology
Sep 2025 86d
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 · JWY Manual Antimicrobial... · Microbiology
Sep 2025 191d
The Sensititre 18-24 hour MIC or Breakpoint Susceptibility System with Amikacin in the dilution range of 0.25-256 ug/mL
K252014 · JWY Manual Antimicrobial... · Microbiology
Aug 2025 62d
The Sensititre 18-24 hour MIC or Breakpoint Susceptibility System with Ciprofloxacin in the dilution range of 0.002-64 ug/mL
K250990 · JWY Manual Antimicrobial... · Microbiology
Jun 2025 91d
The Sensititre 20-24 hour Haemophilus influenzae/Streptococcus pneumoniae (HP) MIC or Breakpoint Susceptibility System with Ceftobiprole in the dilution range of 0.008-16 ug/mL.
K242843 · JWY Manual Antimicrobial... · Microbiology
Jun 2025 273d
The Sensititre 18-24 hour MIC or Breakpoint Susceptibility System with Vancomycin in the dilution range of 0.25-128 ug/mL
K242659 · JWY Manual Antimicrobial... · Microbiology
May 2025 260d
The Sensititre 18-24 hour MIC or Breakpoint Susceptibility System with Moxifloxacin in the dilution range of 0.008-16 ug/mL
K242658 · JWY Manual Antimicrobial... · Microbiology
Apr 2025 223d
The Sensititre YeastOne Susceptibility System with Micafungin in the dilution range of 0.008-16 ?g/mL
K243738 · NGZ Susceptibility Test... · Microbiology
Feb 2025 85d
The Sensititre 20-24 hour Haemophilus influenzae/Streptococcus pneumoniae (HP) MIC or Breakpoint Susceptibility System with Linezolid in the dilution range of 0.12-32 ug/mL
K242905 · JWY Manual Antimicrobial... · Microbiology
Feb 2025 139d
The Sensititre 20-24 hour Haemophilus influenzae/Streptococcus pneumoniae (HP) MIC or Breakpoint Susceptibility System with penicillin in the dilution range of 0.015-32 ug/mL
K243201 · JWY Manual Antimicrobial... · Microbiology
Feb 2025 132d
The Sensititre 18-24 hour MIC or Breakpoint Susceptibility System with Ceftobiprole in the dilution range of 0.008-16 ug/mL
K243169 · JWY Manual Antimicrobial... · Microbiology
Dec 2024 80d
The Sensititre 18-24 hour MIC or Breakpoint Susceptibility System with Linezolid in the dilution range of 0.25-32 ug/mL
K242653 · JWY Manual Antimicrobial... · Microbiology
Dec 2024 92d
The Sensititre 18-24 hour MIC or Breakpoint Susceptibility System with Daptomycin in the dilution range of 0.03-64 ug/mL
K242657 · JWY Manual Antimicrobial... · Microbiology
Nov 2024 83d
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 · JWY Manual Antimicrobial... · Microbiology
Oct 2024 90d
The Sensititre 20 - 24 hour Haemophilus influenzae/Streptococcus pneumoniae (HP) MIC or Breakpoint Susceptibility System with ceftriaxone in the dilution range of 0.015 - 2 ug/ml.
K241967 · JWY Manual Antimicrobial... · Microbiology
Oct 2024 90d
The Sensititre 20 - 24 hour Haemophilus influenzae/Streptococcus pneumoniae (HP) MIC or Breakpoint Susceptibility System with Imipenem in the dilution range of 0.015 - 4 ug/ml.
K240445 · JWY Manual Antimicrobial... · Microbiology
May 2024 91d
Sensititre 20-24 hour Haemophilus influenzaelStreptococcus pneumoniae MIC or Breakpoint Susceptibility System with Ceftolozane-tazobactam in the dilution range of 0.03/4-64/4ug/ml
K232310 · JWY Manual Antimicrobial... · Microbiology
Oct 2023 90d
The Sensititre YeastOne Susceptibility System with Rezafungin in the dilution range of 0.008-8ug/mL
K231433 · NGZ Susceptibility Test... · Microbiology
Aug 2023 106d
Sensititre 20-24-hour Haemophilus influenzae/Streptococcus pneumoniae MIC or Breakpoint Susceptibility System with Dalbavancin in the dilution range of 0.0005-2?g/ml
K231988 · JWY Manual Antimicrobial... · Microbiology
Aug 2023 56d
Sensititre 18-24 hour MIC or Breakpoint Susceptibility System with Sulbactam-durlobactam in the dilution range of 0.015/4-32/4 ug/mL
K231994 · JWY Manual Antimicrobial... · Microbiology
Aug 2023 51d
Sensititre 20-24 hour Haemophilus influenzae/Streptococcus pneumoniae MIC, or Breakpoint Susceptibility System with Imipenem-relebactam in the dilution, range of 0.03/4-128-4ug/ml (Haemophilus influenzae)
K230935 · JWY Manual Antimicrobial... · Microbiology
Jun 2023 88d
Sensititre 20-24-hour Haemophilus influenzae/Streptococcus pneumoniae MIC or Breakpoint Susceptibility System with Delafloxacin in the dilution range of 0.00025-8ug/ml (Streptococcus species) and 0.000125-8ug/ml (Haemophilus influenzae)
K223844 · JWY Manual Antimicrobial... · Microbiology
Mar 2023 89d
Sensititre YeastOne Susceptibility System with Fluconazole in the dilution range of 0.12-128ug/mL
K221198 · NGZ Susceptibility Test... · Microbiology
Mar 2023 318d
The Sensititre YeastOne Susceptibility System with Caspofungin in the dilution range of 0.015-16ug/ml
K221899 · NGZ Susceptibility Test... · Microbiology
Jan 2023 204d
Sensititre 18-24 hour MIC or Breakpoint Susceptibility System with Cefiderocol in the dilution range of 0.03-64 ug/ml
K203741 · JWY Manual Antimicrobial... · Microbiology
Dec 2021 363d
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