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510(k) K252014

The Sensititre 18-24 hour MIC or Breakpoint Susceptibility System with Amikacin in the dilution range of 0.25-256 ug/mL by Thermo Fisher Scientific — Product Code JWY

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 28, 2025
Date Received
June 27, 2025
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Manual Antimicrobial Susceptibility Test Systems
Device Class
Class II
Regulation Number
866.1640
Review Panel
MI
Submission Type

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  • K250990 — The Sensititre 18-24 hour MIC or Breakpoint Susceptibility System with Ciproflox (June 30, 2025)
  • K242843 — The Sensititre 20-24 hour Haemophilus influenzae/Streptococcus pneumoniae (HP) M (June 20, 2025)
  • K242659 — The Sensititre 18-24 hour MIC or Breakpoint Susceptibility System with Vancomyci (May 22, 2025)
  • K242658 — The Sensititre 18-24 hour MIC or Breakpoint Susceptibility System with Moxifloxa (April 15, 2025)
  • K243738 — The Sensititre YeastOne Susceptibility System with Micafungin in the dilution ra (February 27, 2025)
  • K242905 — The Sensititre 20-24 hour Haemophilus influenzae/Streptococcus pneumoniae (HP) M (February 10, 2025)
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  • K243169 — The Sensititre 18-24 hour MIC or Breakpoint Susceptibility System with Ceftobipr (December 19, 2024)

Other clearances for product code JWY

  • K252114 — MTS Aztreonam-Avibactam 0.016/4 - 256/4 µg/mL (October 2, 2025)
  • K252062 — The Sensititre 18-24 hour MIC or Breakpoint Susceptibility System with Colistin (September 25, 2025)
  • K250575 — The Sensititre 18 - 24 hour MIC or Breakpoint Susceptibility System with Aztreon (September 5, 2025)
  • K251580 — MTS Sulbactam-Durlobactam 0.004/4 - 64/4 µg/mL (SUD) (August 20, 2025)
  • K250990 — The Sensititre 18-24 hour MIC or Breakpoint Susceptibility System with Ciproflox (June 30, 2025)
  • K242843 — The Sensititre 20-24 hour Haemophilus influenzae/Streptococcus pneumoniae (HP) M (June 20, 2025)
  • K250856 — ETEST Aztreonam/Avibactam (AZA) (0.016/4-256/4 µg/mL) (June 12, 2025)
  • K242659 — The Sensititre 18-24 hour MIC or Breakpoint Susceptibility System with Vancomyci (May 22, 2025)
  • K250274 — ETEST Imipenem/Relebactam P. aeruginosa (IRPA) (0.008/4-128/4 µg/mL) (April 30, 2025)
  • K242658 — The Sensititre 18-24 hour MIC or Breakpoint Susceptibility System with Moxifloxa (April 15, 2025)