Thermo Fisher Scientific — FDA PCCPs

Thermo Fisher Scientific holds 10 FDA-authorized PCCPs in this tracker. Here is the full list, newest first.

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
K250990The Sensititre 18-24 hour MIC or Breakpoint Susceptibility System with Ciprofloxacin in the dilution range of 0.002-64 ug/mLThermo Fisher Scientific2025-06-30Non-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
K243738The Sensititre YeastOne Susceptibility System with Micafungin in the dilution range of 0.008-16 µg/mLThermo Fisher Scientific2025-02-27Non-AIUnknown
K242905The 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/mLThermo Fisher Scientific2025-02-10Non-AIUnknown
K243201The 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/mLThermo Fisher Scientific2025-02-10Non-AIUnknown

Other companies

Medtronic Minimed, Inc. — FDA PCCPs (5)Hardy Diagnostics — FDA PCCPs (4)Anumana, Inc. — FDA PCCPs (4)Clarius Mobile Health Corp. — FDA PCCPs (4)Liofilchem s.r.l. — FDA PCCPs (3)Centers for Disease Control and Prevention — FDA PCCPs (3)Ceribell, Inc. — FDA PCCPs (3)Therapixel — FDA PCCPs (3)Beckman Coulter, Inc. — FDA PCCPs (3)TriMed, Inc. — FDA PCCPs (3)Subtle Medical, Inc. — FDA PCCPs (2)Artera, Inc. — FDA PCCPs (2)

Want the monitoring teardown?

We read the Thermo Fisher Scientific PCCPs in this list, 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 call

Source: 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.

This page is a factual summary of public FDA records. Sentir Health is not affiliated with or endorsed by the named companies or the U.S. Food and Drug Administration. Spot an error? Request a correction.