JTN — Susceptibility Test Discs, Antimicrobial Class II

FDA Device Classification

Classification Details

Product Code
JTN
Device Class
Class II
Regulation Number
866.1620
Submission Type
Review Panel
MI
Medical Specialty
Microbiology
Implant
No

Recent 510(k) Clearances

K-NumberApplicantDevice NameDate
K251337thermo fisher scientific (oxoid ltd.)Thermo Scientific Oxoid Gepotidacin Disc (10 µg) GEP10December 5, 2025
K253105hardy diagnosticsHardyDisk AST Cefiderocol 30µg (FDC30)November 20, 2025
K251879liofilchemSulopenem SPM 2 µgAugust 12, 2025
K250956hardy diagnosticsHardyDisk AST Gepotidacin 10µg (GEP10)June 26, 2025
K250885liofilchemCeftobiprole BPR 5 µg DiscJune 23, 2025
K250789thermo fisher scientific (oxoid ltd.)Thermo Scientific Oxoid Aztreonam/Avibactam Disc (30/20 µg) AZA50June 12, 2025
K250454hardy diagnosticsHardyDisk Aztreonam/Avibactam 30/20µg (AZA50)May 15, 2025
K241060hardy diagnosticsHardyDisk AST Cefiderocol 30µg (FDC30)July 18, 2024
K231806oxoid limited (part of thermo fisher scientific)Thermo Scientific Oxoid Rezafungin Disc (5 µg) RZF5March 22, 2024
K232276oxoid limited (part of thermo fisher scientific)Thermo Scientific Oxoid Sulbactam/Durlobactam Disc (10/10 µg) SUD20October 6, 2023
K231568hardy diagnosticsHardyDisk AST Sulbactam/Durlobactam 10/10µg (SUD20)July 6, 2023
K230651becton, dickinson andBD BBL™ Sensi-Disc™ Lefamulin 20µg (LMU-20)June 7, 2023
K230827hardy diagnosticsHardyDisk AST Rezafungin 5µg (RZF5)June 1, 2023
K221826becton, dickinson andBD BBL Sensi-Disc Cefiderocol 30ug (FDC-30)December 21, 2022
K203336oxoid limited (part of thermo fisher scientific)Thermo Scientific Oxoid Omadacycline Disc (30 ug) OMC30September 15, 2022
K210873oxoid limited (part of thermo fisher scientific)Thermo Scientific Oxoid Lefamulin Disc (20µg) LMU20October 27, 2021
K203700oxoid limited (part of thermo fisher scientific)Thermo Scientific Oxoid Cefiderocol Disc (30 µg) FDC30July 30, 2021
K193508oxoid limited (part of thermo fisher scientific)Thermo Scientific Oxoid Eravacycline Disc (20ug) ERV20December 4, 2020
K193504hardy diagnosticsHardyDisk AST Cefiderocol 30ug (FDC30)January 23, 2020
K192326hardy diagnosticsHardyDisk AST Lefamulin 20µg (LMU20)September 19, 2019