Panels › Microbiology › Product code JTN · Class 2
Susceptibility Test Discs, Antimicrobial
Regulation 866.1620
6510(k)s in 12 months (331 all time)
1recalls in 12 months (47 all time)
38recalls that name a 510(k)
Top companies in JTN
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Aug 20, 2026 | K262113 | HardyDisk AST Tebipenem 10µg (TBP10) Hardy Diagnostics | JTN |
| Jul 24, 2026 | K261781 | Thermo Scientific Oxoid Cefepime/Zidebactam Disc (30/30 µg) FPZ60 Thermo Fisher Scientific (Oxoid Ltd.), GB | JTN |
| Jul 23, 2026 | K261853 | Gepotidacin GEP 10 µg Liofilchem, Inc. | JTN |
| May 11, 2026 | K260842 | HardyDisk AST Gepotidacin 10µg (GEP10) Hardy Diagnostics | JTN |
| Dec 5, 2025 | K251337 | Thermo Scientific Oxoid Gepotidacin Disc (10 µg) GEP10 Thermo Fisher Scientific (Oxoid Ltd.), GB | JTN |
| Nov 20, 2025 | K253105 | HardyDisk AST Cefiderocol 30µg (FDC30) Hardy Diagnostics | JTN |
| Aug 12, 2025 | K251879 | Sulopenem SPM 2 µg Liofilchem | JTN |
| Jun 26, 2025 | K250956 | HardyDisk AST Gepotidacin 10µg (GEP10) Hardy Diagnostics | JTN |
| Jun 23, 2025 | K250885 | Ceftobiprole BPR 5 µg Disc Liofilchem, Inc. | JTN |
| Jun 12, 2025 | K250789 | Thermo Scientific Oxoid Aztreonam/Avibactam Disc (30/20 µg) AZA50 Thermo Fisher Scientific (Oxoid Ltd.), GB | JTN |
| May 15, 2025 | K250454 | HardyDisk Aztreonam/Avibactam 30/20µg (AZA50) Hardy Diagnostics | JTN |
| Jul 18, 2024 | K241060 | HardyDisk AST Cefiderocol 30µg (FDC30) Hardy Diagnostics | JTN |
| Mar 22, 2024 | K231806 | Thermo Scientific Oxoid Rezafungin Disc (5 µg) RZF5 Oxoid Limited (Part of Thermo Fisher Scientific), GB | JTN |
| Oct 6, 2023 | K232276 | Thermo Scientific Oxoid Sulbactam/Durlobactam Disc (10/10 µg) SUD20 Oxoid Limited (Part of Thermo Fisher Scientific), GB | JTN |
| Jul 6, 2023 | K231568 | HardyDisk AST Sulbactam/Durlobactam 10/10µg (SUD20) Hardy Diagnostics | JTN |
| Jun 7, 2023 | K230651 | BD BBL Sensi-Disc Lefamulin 20µg (LMU-20) Becton, Dickinson and Company | JTN |
| Jun 1, 2023 | K230827 | HardyDisk AST Rezafungin 5µg (RZF5) Hardy Diagnostics | JTN |
| Dec 21, 2022 | K221826 | BD BBL Sensi-Disc Cefiderocol 30ug (FDC-30) Becton, Dickinson and Company | JTN |
| Sep 15, 2022 | K203336 | Thermo Scientific Oxoid Omadacycline Disc (30 ug) OMC30 Oxoid Limited (Part of Thermo Fisher Scientific), GB | JTN |
| Oct 27, 2021 | K210873 | Thermo Scientific Oxoid Lefamulin Disc (20µg) LMU20 Oxoid Limited (Part of Thermo Fisher Scientific), GB | JTN |
| Jul 30, 2021 | K203700 | Thermo Scientific Oxoid Cefiderocol Disc (30 µg) FDC30 Oxoid Limited (Part of Thermo Fisher Scientific), GB | JTN |
| Dec 4, 2020 | K193508 | Thermo Scientific Oxoid Eravacycline Disc (20ug) ERV20 Oxoid Limited (Part of Thermo Fisher Scientific), GB | JTN |
| Jan 23, 2020 | K193504 | HardyDisk AST Cefiderocol 30ug (FDC30) Hardy Diagnostics | JTN |
| Sep 19, 2019 | K192326 | HardyDisk AST Lefamulin 20µg (LMU20) Hardy Diagnostics | JTN |
| Jul 31, 2019 | K191931 | HardyDisk AST Imipenem/relebactam 10/25µg (IMR10/25) Hardy Diagnostics | JTN |
| Jan 18, 2019 | K183298 | HardyDisk AST Omadacycline 30µg (OMC30) Hardy Diagnostics | JTN |
| Sep 27, 2018 | K181975 | Thermo Scientific Oxoid Meropenem/Vaborbactam Disc (30µg) MEV30 Oxoid Limited (Part of Thermo Fisher Scientific), GB | JTN |
| Sep 26, 2018 | K182357 | HardyDisk AST Eravacycline 20µg (ERV20) Hardy Diagnostics | JTN |
| Jul 10, 2018 | K181700 | HardyDisk AST Plazomicin 30ug (PLZ30) Hardy Diagnostics | JTN |
| Oct 3, 2017 | K172621 | HardyDisk Meropenem/Vaborbactam 20/10µg (MEV30) Hardy Diagnostics | JTN |
| Aug 1, 2017 | K171975 | HardyDisk AST Delafloxacin 5 µg (DLX5) Hardy Diagnostics | JTN |
| Mar 14, 2017 | K170127 | HardyDisk Ceftolozane/Tazobactam, (30/10 ug)-C/T40 Hardy Diagnostics | JTN |
| Nov 24, 2015 | K152846 | HardyDisk AST Ceftolozane/Tazobactam, (30/10ug)- C/T40 Hardy Diagnostics | JTN |
| Nov 24, 2015 | K152838 | HardyDisk AST Ceftazidime/Avibactam, (30/20ug)-CZA50 Hardy Diagnostics | JTN |
| Oct 13, 2015 | K152516 | BD BBL Sensi-Disc Ceftazidime Avibactam (30/20ug), Antimicrobial Susceptibility Test Disks Becton, Dickinson and Company | JTN |
| Oct 18, 2011 | K112586 | CEFTAROLINE 30 MICROGRAMS, BBL(TM) SENSI-DISC(TM) Becton, Dickinson and Company (BD) | JTN |
| Dec 17, 2010 | K103538 | HARDYDISK AST CEFTAROLINE, 30 UG MODEL Z939 Hardy Diagnostics | JTN |
| Mar 29, 2010 | K100722 | TELAVANCIN 30 UG, BBL SENSI-DISC Becton, Dickinson and Company | JTN |
| Jan 8, 2010 | K093807 | HARDYDISK AST TELAVANCIN,30UG Hardy Diagnostics | JTN |
| Oct 6, 2008 | K082271 | FLUCONAZOLE 25UG BBL SENSI-DISC Becton, Dickinson & CO | JTN |
| Oct 2, 2008 | K082272 | VORICONAZOLE 1UG BBL SENSI-DISC Becton, Dickinson & CO | JTN |
| May 12, 2008 | K080998 | DORIPENEM 10UG BBL SENSI-DISC Becton, Dickinson & CO | JTN |
| Jan 29, 2008 | K080019 | HARDYDISK AST DORIPENEM 10 UG Hardy Diagnostics | JTN |
| Mar 14, 2007 | K070262 | ERTAPENEM ANTIMICROBIAL SUSCEPTIBILITY TEST DISC Oxoid , Ltd., GB | JTN |
| Aug 23, 2006 | K062245 | HARDY DISK AST TIGECYCLINE 15 UG, MODELZ936 Hardy Diagnostics | JTN |
| Mar 17, 2006 | K060286 | TIGECYCLINE ANTIMICROBIAL SUSCEPTIBILITY TEST DISC Oxoid , Ltd., GB | JTN |
| Nov 17, 2005 | K052853 | TIGECYCLINE 15UG BBL SENSI-DISC Becton, Dickinson & CO | JTN |
| Nov 14, 2005 | K052876 | TELITHROMYCIN 15UG BBL SENSI-DISC Becton, Dickinson & CO | JTN |
| Feb 10, 2005 | K050062 | GEMIFLOXACIN, 5UG BBL SENSI-DISC Becton, Dickinson & CO | JTN |
| Sep 14, 2004 | K042157 | DAPTOMYCIN ANTIMICROBIAL SUSCEPTIBILITY TEST DISC Oxoid , Ltd., GB | JTN |
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