FDA.report

510(k) K260696

Device
MTS Gepotidacin 0.016-256 µg/mL
Applicant
Liofilchem s.r.l.
510(k) number
K260696
Product code
JWY
Decision
Substantially Equivalent (SESE)
Decision date
2026-04-17
Date received
2026-03-03
Regulation
866.1640
Classification name
Manual Antimicrobial Susceptibility Test Systems
Medical specialty
Microbiology
Review panel
Microbiology
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
N

Related Records

Applicant Contact

Contact
Fabio Brocco
Address
Via Scozia, Zona Industriale 64026 Roseto Degli Abruzzi IT

FDA Registration Numbers

Source Documents

510(k) summary PDF

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Other 510(k) Records For Product Code JWY

510(k)DeviceApplicantDecision date
K260447ETEST Gepotidacin (GEP) (0.016-256 µg/mL)bioMérieux SA2026-04-21
K252114MTS Aztreonam-Avibactam 0.016/4 - 256/4 µg/mLLiofilchem s.r.l.2025-10-02
K252062The Sensititre 18-24 hour MIC or Breakpoint Susceptibility System with Colistin in the dilution range of 0.12-16 ug/mLThermo Fisher Scientific2025-09-25
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 Scientific2025-09-05
K252014The Sensititre 18-24 hour MIC or Breakpoint Susceptibility System with Amikacin in the dilution range of 0.25-256 ug/mLThermo Fisher Scientific2025-08-28
K251580MTS Sulbactam-Durlobactam 0.004/4 - 64/4 µg/mL (SUD)Liofilchem s.r.l.2025-08-20
K250990The Sensititre 18-24 hour MIC or Breakpoint Susceptibility System with Ciprofloxacin in the dilution range of 0.002-64 ug/mLThermo Fisher Scientific2025-06-30
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 Scientific2025-06-20
K250856ETEST Aztreonam/Avibactam (AZA) (0.016/4-256/4 µg/mL)Biomérieux2025-06-12
K242659The Sensititre 18-24 hour MIC or Breakpoint Susceptibility System with Vancomycin in the dilution range of 0.25-128 ug/mLThermo Fisher Scientific2025-05-22
K250274ETEST Imipenem/Relebactam P. aeruginosa (IRPA) (0.008/4-128/4 µg/mL)Biomerieux S.A.2025-04-30
K242658The Sensititre 18-24 hour MIC or Breakpoint Susceptibility System with Moxifloxacin in the dilution range of 0.008-16 ug/mLThermo Fisher Scientific2025-04-15
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 Scientific2025-02-10
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 Scientific2025-02-10
K243202MTS Ceftobiprole 0.002-32 µg/mLLiofilchem s.r.l.2025-01-30