The Sensititre 18-24 hour MIC or Breakpoint Susceptibility System with Ciprofloxacin in the dilution range of 0.002-64 ug/mL
Thermo Fisher Scientific · K250990
FDA-authorized Predetermined Change Control Plan
- Company
- Thermo Fisher Scientific
- 510(k)/De Novo #
- K250990
- Decision date
- 2025-06-30
- Panel
- Microbiology
- Pathway
- 510(k)
- Category
- Non-AI
- PCCP type
- Unknown
- Monitoring commitment
- Unknown
Other PCCPs from Thermo Fisher Scientific
- K252062The Sensititre 18-24 hour MIC or Breakpoint Susceptibility System with Colistin in the dilution range of 0.12-16 ug/mLThermo Fisher Scientific2025-09-25Non-AIUnknown
- K250575The Sensititre 18 - 24 hour MIC or Breakpoint Susceptibility System with Aztreonam/avibactam in the dilution range of 0.008/4 - 64/4 ug/mLThermo Fisher Scientific2025-09-05Non-AIUnknown
- K252014The Sensititre 18-24 hour MIC or Breakpoint Susceptibility System with Amikacin in the dilution range of 0.25-256 ug/mLThermo Fisher Scientific2025-08-28Non-AIUnknown
- K242843The 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.Thermo Fisher Scientific2025-06-20Non-AIUnknown
- K242659The Sensititre 18-24 hour MIC or Breakpoint Susceptibility System with Vancomycin in the dilution range of 0.25-128 ug/mLThermo Fisher Scientific2025-05-22Non-AIUnknown
- K242658The Sensititre 18-24 hour MIC or Breakpoint Susceptibility System with Moxifloxacin in the dilution range of 0.008-16 ug/mLThermo Fisher Scientific2025-04-15Non-AIUnknown
Other Microbiology PCCPs
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- K260447ETEST Gepotidacin (GEP) (0.016-256 µg/mL)bioMérieux SA2026-04-21Non-AIPanel expansion
- K260696MTS Gepotidacin 0.016-256 µg/mLLiofilchem s.r.l.2026-04-17Non-AIPanel expansion
- K260282VITEK 2 AST-Streptococcus Inducible Clindamycin ResistancebioMerieux, Inc.2026-04-15Non-AIUnknown
- K253573ASTar BC G- KitQ-Linea AB2026-04-15AI hardwarePanel expansion
- K260281VITEK 2 AST-Streptococcus Cefuroxime (<=0.125 - >=8 µg/mL)BIOMERIEUX2026-03-26Non-AIUnknown
Want the monitoring teardown?
We read the PCCP for The Sensititre 18-24 hour MIC or Breakpoint Susceptibility System with Ciprofloxacin in the dilution range of 0.002-64 ug/mL, then map the post-market monitoring that its modification protocol requires, including the deployment-period evidence most teams can't reconstruct at modification time. Sentir is the independent system of record that produces it.
Book a callSource: U.S. FDA public records (openFDA 510(k)/De Novo databases and accessdata.fda.gov). PCCP type and category are editorial classifications based on public documents, not official FDA designations.
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