Product code JTN
- Device name
- Susceptibility Test Discs, Antimicrobial
- Medical specialty
- Microbiology
- Device class
- 2
- Regulation number
- 866.1620
- Review panel
- MI
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- Y
- Summary malfunction reporting
- Ineligible
- Source
- FDA openFDA device classification dataset
Related PMA Records#
| PMA | Device | Applicant | Decision date |
|---|---|---|---|
| N60242 | MS 2 AUTOMATED SYSTEM | Abbott Laboratories | 1979-05-04 |
Related 510(k) Records#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K260842 | HardyDisk AST Gepotidacin 10µg (GEP10) | Hardy Diagnostics | 2026-05-11 |
| K251337 | Thermo Scientific Oxoid Gepotidacin Disc (10 µg) GEP10 | Thermo Fisher Scientific (Oxoid Ltd.) | 2025-12-05 |
| K253105 | HardyDisk AST Cefiderocol 30µg (FDC30) | Hardy Diagnostics | 2025-11-20 |
| K251879 | Sulopenem SPM 2 µg | Liofilchem | 2025-08-12 |
| K250956 | HardyDisk AST Gepotidacin 10µg (GEP10) | Hardy Diagnostics | 2025-06-26 |
| K250885 | Ceftobiprole BPR 5 µg Disc | Liofilchem, Inc. | 2025-06-23 |
| K250789 | Thermo Scientific Oxoid Aztreonam/Avibactam Disc (30/20 µg) AZA50 | Thermo Fisher Scientific (Oxoid Ltd.) | 2025-06-12 |
| K250454 | HardyDisk Aztreonam/Avibactam 30/20µg (AZA50) | Hardy Diagnostics | 2025-05-15 |
| K241060 | HardyDisk AST Cefiderocol 30µg (FDC30) | Hardy Diagnostics | 2024-07-18 |
| K231806 | Thermo Scientific Oxoid Rezafungin Disc (5 µg) RZF5 | Oxoid Limited (Part of Thermo Fisher Scientific) | 2024-03-22 |
| K232276 | Thermo Scientific Oxoid Sulbactam/Durlobactam Disc (10/10 µg) SUD20 | Oxoid Limited (Part of Thermo Fisher Scientific) | 2023-10-06 |
| K231568 | HardyDisk AST Sulbactam/Durlobactam 10/10µg (SUD20) | Hardy Diagnostics | 2023-07-06 |
| K230651 | BD BBL™ Sensi-Disc™ Lefamulin 20µg (LMU-20) | Becton, Dickinson and Company | 2023-06-07 |
| K230827 | HardyDisk AST Rezafungin 5µg (RZF5) | Hardy Diagnostics | 2023-06-01 |
| K221826 | BD BBL Sensi-Disc Cefiderocol 30ug (FDC-30) | Becton, Dickinson and Company | 2022-12-21 |
| K203336 | Thermo Scientific Oxoid Omadacycline Disc (30 ug) OMC30 | Oxoid Limited (Part of Thermo Fisher Scientific) | 2022-09-15 |
| K210873 | Thermo Scientific Oxoid Lefamulin Disc (20µg) LMU20 | Oxoid Limited (Part of Thermo Fisher Scientific) | 2021-10-27 |
| K203700 | Thermo Scientific Oxoid Cefiderocol Disc (30 µg) FDC30 | Oxoid Limited (Part of Thermo Fisher Scientific) | 2021-07-30 |
| K193508 | Thermo Scientific Oxoid Eravacycline Disc (20ug) ERV20 | Oxoid Limited (Part of Thermo Fisher Scientific) | 2020-12-04 |
| K193504 | HardyDisk AST Cefiderocol 30ug (FDC30) | Hardy Diagnostics | 2020-01-23 |
| K192326 | HardyDisk AST Lefamulin 20µg (LMU20) | Hardy Diagnostics | 2019-09-19 |
| K191931 | HardyDisk AST Imipenem/relebactam 10/25µg (IMR10/25) | Hardy Diagnostics | 2019-07-31 |
| K183298 | HardyDisk AST Omadacycline 30µg (OMC30) | Hardy Diagnostics | 2019-01-18 |
| K181975 | Thermo Scientific Oxoid Meropenem/Vaborbactam Disc (30µg) MEV30 | Oxoid Limited (Part of Thermo Fisher Scientific) | 2018-09-27 |
| K182357 | HardyDisk AST Eravacycline 20µg (ERV20) | Hardy Diagnostics | 2018-09-26 |
| K181700 | HardyDisk AST Plazomicin 30ug (PLZ30) | Hardy Diagnostics | 2018-07-10 |
| K172621 | HardyDisk Meropenem/Vaborbactam 20/10µg (MEV30) | Hardy Diagnostics | 2017-10-03 |
| K171975 | HardyDisk AST Delafloxacin 5 µg (DLX5) | Hardy Diagnostics | 2017-08-01 |
| K170127 | HardyDisk Ceftolozane/Tazobactam, (30/10 ug)-C/T40 | Hardy Diagnostics | 2017-03-14 |
| K152846 | HardyDisk AST Ceftolozane/Tazobactam, (30/10ug)- C/T40 | Hardy Diagnostics | 2015-11-24 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 05032384550784 | Thermo Scientific Oxoid Gepotidacin Disc (10 ug) GEP10 | OXOID LIMITED | 2026-01-21 |
| 05032384533121 | Oxoid Aztreonam/Avibactam Disc (30/20ug) AZA50 | OXOID LIMITED | 2025-12-12 |
| 00816576027194 | HardyDisk™ | HARDY DIAGNOSTICS | 2025-08-08 |
| 00816576027200 | HardyDisk™ | HARDY DIAGNOSTICS | 2025-08-08 |
| 00816576027088 | HardyDisk™ | HARDY DIAGNOSTICS | 2025-08-08 |
| 00816576027057 | HardyDisk™ | HARDY DIAGNOSTICS | 2025-07-18 |
| 00816576027071 | HardyDisk™ | HARDY DIAGNOSTICS | 2025-07-14 |
| 00816576026975 | HardyDisk™ | HARDY DIAGNOSTICS | 2025-07-14 |
| 05032384516018 | Oxoid Eravacycline Disc (20ug) ERV20 Antimicrobial Susceptibility Test Discs | OXOID LIMITED | 2024-10-28 |
| 05032384537723 | Oxoid Sulbactam/Durlobactam (10/10ug) SUD20 Antimicrobial Susceptibility Test Di | OXOID LIMITED | 2024-10-28 |
| 05032384579945 | Oxoid Sulbactam/Durlobactam (10/10ug) SUD20 Antimicrobial Susceptibility Test Di | OXOID LIMITED | 2024-10-28 |
| 05032384580231 | Oxoid Eravacycline Disc (20ug) ERV20 Antimicrobial Susceptibility Test Discs | OXOID LIMITED | 2024-10-28 |
| 05032384526123 | Oxoid Lefamulin (20ug) LMU20 Antimicrobial Susceptibility Test Discs | OXOID LIMITED | 2024-10-01 |
| 05032384574964 | Ceftazidime (10 ug) CAZ10 Antimicrobial Susceptibility Test Discs | OXOID LIMITED | 2024-07-05 |
| 05032384088423 | Ceftazidime (10 ug) CAZ10 Antimicrobial Susceptibility Test Discs | OXOID LIMITED | 2024-07-05 |
| 00819398020725 | HardyDisk™ | HARDY DIAGNOSTICS | 2023-11-21 |
| 00819398020923 | HardyDisk™ | HARDY DIAGNOSTICS | 2023-11-21 |
| 00819398020732 | HardyDisk™ | HARDY DIAGNOSTICS | 2023-11-21 |
| 00819398021548 | HardyDisk™ | HARDY DIAGNOSTICS | 2023-09-08 |
| 00819398021180 | HardyDisk™ | HARDY DIAGNOSTICS | 2023-09-08 |
| 00819398021197 | HardyDisk™ | HARDY DIAGNOSTICS | 2023-09-08 |
| 00382902322559 | BD BBL™ Sensi-Disc™ Cefiderocol 30 µg | BECTON, DICKINSON AND COMPANY | 2023-06-16 |
| 05032384526116 | NA | OXOID LIMITED | 2021-12-07 |
| 00816576028283 | HardyDisk™ | HARDY DIAGNOSTICS | 2020-08-07 |
| 00816576028306 | HardyDisk™ | HARDY DIAGNOSTICS | 2020-08-07 |
| 00816576028290 | HardyDisk™ | HARDY DIAGNOSTICS | 2020-08-07 |
| 00819398028110 | HardyDisk™ | HARDY DIAGNOSTICS | 2020-03-03 |
| 00819398028103 | HardyDisk™ | HARDY DIAGNOSTICS | 2020-03-03 |
| 00816576023394 | HardyDisk™ | HARDY DIAGNOSTICS | 2019-02-18 |
| 00816576023400 | HardyDisk™ | HARDY DIAGNOSTICS | 2019-02-18 |