FDA.report

510(k) K260447

Device
ETEST Gepotidacin (GEP) (0.016-256 µg/mL)
Applicant
bioMérieux SA
510(k) number
K260447
Product code
JWY
Decision
Substantially Equivalent (SESE)
Decision date
2026-04-21
Date received
2026-02-11
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
Stéphanie Millon-Serme
Address
376 Chemin De L'Orme Marcy-L'Etoile FR 69280 69280

FDA Registration Numbers

Source Documents

510(k) summary PDF

Other 510(k) Records For Product Code JWY

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K260696MTS Gepotidacin 0.016-256 µg/mLLiofilchem s.r.l.2026-04-17
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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