FDA Product Code
FDA Product Code JTN — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Microbiology
- 21 CFR Citation
- 866.1620
510(k) Clearances — 331 records · page 1 of 4
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K262113 | HardyDisk AST Tebipenem 10µg (TBP10) | Hardy Diagnostics | 2026-08-20 | Traditional | PDF ↗ |
| K261781 | Thermo Scientific Oxoid Cefepime/Zidebactam Disc (30/30 µg) FPZ60 | Thermo Fisher Scientific (Oxoid Ltd.) | 2026-07-24 | Traditional | PDF ↗ |
| K261853 | Gepotidacin GEP 10 µg | Liofilchem, Inc. | 2026-07-23 | Traditional | PDF ↗ |
| K260842 | HardyDisk AST Gepotidacin 10µg (GEP10) | Hardy Diagnostics | 2026-05-11 | Traditional | PDF ↗ |
| K251337 | Thermo Scientific Oxoid Gepotidacin Disc (10 µg) GEP10 | Thermo Fisher Scientific (Oxoid Ltd.) | 2025-12-05 | Traditional | PDF ↗ |
| K253105 | HardyDisk AST Cefiderocol 30µg (FDC30) | Hardy Diagnostics | 2025-11-20 | Traditional | PDF ↗ |
| K251879 | Sulopenem SPM 2 µg | Liofilchem | 2025-08-12 | Traditional | PDF ↗ |
| K250956 | HardyDisk AST Gepotidacin 10µg (GEP10) | Hardy Diagnostics | 2025-06-26 | Traditional | PDF ↗ |
| K250885 | Ceftobiprole BPR 5 µg Disc | Liofilchem, Inc. | 2025-06-23 | Traditional | PDF ↗ |
| K250789 | Thermo Scientific Oxoid Aztreonam/Avibactam Disc (30/20 µg) AZA50 | Thermo Fisher Scientific (Oxoid Ltd.) | 2025-06-12 | Traditional | PDF ↗ |
| K250454 | HardyDisk Aztreonam/Avibactam 30/20µg (AZA50) | Hardy Diagnostics | 2025-05-15 | Traditional | PDF ↗ |
| K241060 | HardyDisk AST Cefiderocol 30µg (FDC30) | Hardy Diagnostics | 2024-07-18 | Traditional | PDF ↗ |
| K231806 | Thermo Scientific Oxoid Rezafungin Disc (5 µg) RZF5 | Oxoid Limited (Part of Thermo Fisher Scientific) | 2024-03-22 | Traditional | PDF ↗ |
| K232276 | Thermo Scientific Oxoid Sulbactam/Durlobactam Disc (10/10 µg) SUD20 | Oxoid Limited (Part of Thermo Fisher Scientific) | 2023-10-06 | Traditional | PDF ↗ |
| K231568 | HardyDisk AST Sulbactam/Durlobactam 10/10µg (SUD20) | Hardy Diagnostics | 2023-07-06 | Traditional | PDF ↗ |
| K230651 | BD BBL Sensi-Disc Lefamulin 20µg (LMU-20) | Becton, Dickinson and Company | 2023-06-07 | Traditional | PDF ↗ |
| K230827 | HardyDisk AST Rezafungin 5µg (RZF5) | Hardy Diagnostics | 2023-06-01 | Traditional | PDF ↗ |
| K221826 | BD BBL Sensi-Disc Cefiderocol 30ug (FDC-30) | Becton, Dickinson and Company | 2022-12-21 | Traditional | PDF ↗ |
| K203336 | Thermo Scientific Oxoid Omadacycline Disc (30 ug) OMC30 | Oxoid Limited (Part of Thermo Fisher Scientific) | 2022-09-15 | Traditional | PDF ↗ |
| K210873 | Thermo Scientific Oxoid Lefamulin Disc (20µg) LMU20 | Oxoid Limited (Part of Thermo Fisher Scientific) | 2021-10-27 | Traditional | PDF ↗ |
| K203700 | Thermo Scientific Oxoid Cefiderocol Disc (30 µg) FDC30 | Oxoid Limited (Part of Thermo Fisher Scientific) | 2021-07-30 | Traditional | PDF ↗ |
| K193508 | Thermo Scientific Oxoid Eravacycline Disc (20ug) ERV20 | Oxoid Limited (Part of Thermo Fisher Scientific) | 2020-12-04 | Traditional | PDF ↗ |
| K193504 | HardyDisk AST Cefiderocol 30ug (FDC30) | Hardy Diagnostics | 2020-01-23 | Traditional | PDF ↗ |
| K192326 | HardyDisk AST Lefamulin 20µg (LMU20) | Hardy Diagnostics | 2019-09-19 | Traditional | PDF ↗ |
| K191931 | HardyDisk AST Imipenem/relebactam 10/25µg (IMR10/25) | Hardy Diagnostics | 2019-07-31 | Traditional | PDF ↗ |
| K183298 | HardyDisk AST Omadacycline 30µg (OMC30) | Hardy Diagnostics | 2019-01-18 | Traditional | PDF ↗ |
| K181975 | Thermo Scientific Oxoid Meropenem/Vaborbactam Disc (30µg) MEV30 | Oxoid Limited (Part of Thermo Fisher Scientific) | 2018-09-27 | Traditional | PDF ↗ |
| K182357 | HardyDisk AST Eravacycline 20µg (ERV20) | Hardy Diagnostics | 2018-09-26 | Traditional | PDF ↗ |
| K181700 | HardyDisk AST Plazomicin 30ug (PLZ30) | Hardy Diagnostics | 2018-07-10 | Traditional | PDF ↗ |
| K172621 | HardyDisk Meropenem/Vaborbactam 20/10µg (MEV30) | Hardy Diagnostics | 2017-10-03 | Traditional | PDF ↗ |
| K171975 | HardyDisk AST Delafloxacin 5 µg (DLX5) | Hardy Diagnostics | 2017-08-01 | Traditional | PDF ↗ |
| K170127 | HardyDisk Ceftolozane/Tazobactam, (30/10 ug)-C/T40 | Hardy Diagnostics | 2017-03-14 | Traditional | PDF ↗ |
| K152838 | HardyDisk AST Ceftazidime/Avibactam, (30/20ug)-CZA50 | Hardy Diagnostics | 2015-11-24 | Traditional | PDF ↗ |
| K152846 | HardyDisk AST Ceftolozane/Tazobactam, (30/10ug)- C/T40 | Hardy Diagnostics | 2015-11-24 | Traditional | PDF ↗ |
| K152516 | BD BBL Sensi-Disc Ceftazidime Avibactam (30/20ug), Antimicrobial Susceptibility Test Disks | Becton, Dickinson and Company | 2015-10-13 | Traditional | PDF ↗ |
| K112586 | CEFTAROLINE 30 MICROGRAMS, BBL(TM) SENSI-DISC(TM) | Becton, Dickinson and Company (BD) | 2011-10-18 | Traditional | PDF ↗ |
| K103538 | HARDYDISK AST CEFTAROLINE, 30 UG MODEL Z939 | Hardy Diagnostics | 2010-12-17 | Traditional | PDF ↗ |
| K100722 | TELAVANCIN 30 UG, BBL SENSI-DISC | Becton, Dickinson and Company | 2010-03-29 | Traditional | PDF ↗ |
| K093807 | HARDYDISK AST TELAVANCIN,30UG | Hardy Diagnostics | 2010-01-08 | Traditional | PDF ↗ |
| K082271 | FLUCONAZOLE 25UG BBL SENSI-DISC | Becton, Dickinson & CO | 2008-10-06 | Traditional | PDF ↗ |
| K082272 | VORICONAZOLE 1UG BBL SENSI-DISC | Becton, Dickinson & CO | 2008-10-02 | Traditional | PDF ↗ |
| K080998 | DORIPENEM 10UG BBL SENSI-DISC | Becton, Dickinson & CO | 2008-05-12 | Traditional | PDF ↗ |
| K080019 | HARDYDISK AST DORIPENEM 10 UG | Hardy Diagnostics | 2008-01-29 | Traditional | PDF ↗ |
| K070262 | ERTAPENEM ANTIMICROBIAL SUSCEPTIBILITY TEST DISC | Oxoid , Ltd. | 2007-03-14 | Traditional | PDF ↗ |
| K062245 | HARDY DISK AST TIGECYCLINE 15 UG, MODELZ936 | Hardy Diagnostics | 2006-08-23 | Traditional | PDF ↗ |
| K060286 | TIGECYCLINE ANTIMICROBIAL SUSCEPTIBILITY TEST DISC | Oxoid , Ltd. | 2006-03-17 | Traditional | PDF ↗ |
| K052853 | TIGECYCLINE 15UG BBL SENSI-DISC | Becton, Dickinson & CO | 2005-11-17 | Traditional | PDF ↗ |
| K052876 | TELITHROMYCIN 15UG BBL SENSI-DISC | Becton, Dickinson & CO | 2005-11-14 | Traditional | PDF ↗ |
| K050062 | GEMIFLOXACIN, 5UG BBL SENSI-DISC | Becton, Dickinson & CO | 2005-02-10 | Traditional | PDF ↗ |
| K042157 | DAPTOMYCIN ANTIMICROBIAL SUSCEPTIBILITY TEST DISC | Oxoid , Ltd. | 2004-09-14 | Traditional | PDF ↗ |
| K020842 | ERTAPENEM 10UG BBL SENSI-DISC | Becton, Dickinson & CO | 2002-05-15 | Traditional | PDF ↗ |
| K011384 | HARDYDISK NOVOBIOCIN, 30MCG, MODEL Z883 | Hardy Diagnostics | 2001-06-13 | Traditional | PDF ↗ |
| K011385 | HARDKYDISK NEOMYCIN, 30 MCG | Hardy Diagnostics | 2001-05-18 | Traditional | PDF ↗ |
| K011086 | HARDYDISK BACITRACIN, 10MCG, MODEL Z927 | Hardy Diagnostics | 2001-04-26 | Traditional | PDF ↗ |
| K010536 | MOXIFLOXACIN ANTIMICROBIAL SUSCEPTIBILITY TEST DISC | Oxoid , Ltd. | 2001-04-24 | Traditional | PDF ↗ |
| K010537 | LINEZOLID ANTIMICROBIAL SUSCEPTIBILITY TEST DISC | Oxoid , Ltd. | 2001-04-24 | Traditional | PDF ↗ |
| K003690 | HARDYDISK SULFISOXAZOLE | Hardy Diagnostics | 2001-01-25 | Traditional | PDF ↗ |
| K003554 | HARDYDISK TRIMETHOPRIM 5MCG | Hardy Diagnostics | 2001-01-19 | Traditional | PDF ↗ |
| K003556 | HARDYDISK AMOXICILLIN/CLAVULANIC ACID, 20/10MCG | Hardy Diagnostics | 2001-01-17 | Traditional | PDF ↗ |
| K003537 | HARDYDISK RIFAMPIN, 5MCG | Hardy Diagnostics | 2001-01-12 | Traditional | PDF ↗ |
| K003686 | HARDYDISK TICARCILLIN/CLAVULANIC ACID, 85MCG | Hardy Diagnostics | 2001-01-12 | Traditional | PDF ↗ |
| K003536 | HARDYDISK NAFCILLIN, 1 MCG | Hardy Diagnostics | 2001-01-12 | Traditional | PDF ↗ |
| K003532 | HARDY DISK, CEFPODOXINE, 10MCG | Hardy Diagnostics | 2000-12-13 | Traditional | PDF ↗ |
| K002662 | HARDYDISK CLINDAMYCIN, 2MCG | Hardy Diagnostics | 2000-11-02 | Traditional | PDF ↗ |
| K002661 | HARDYDISK CEFOTETAN, 30MCG | Hardy Diagnostics | 2000-10-26 | Traditional | PDF ↗ |
| K002369 | HARDYDISK GENTAMICIN, 120MCG | Hardy Diagnostics | 2000-10-26 | Traditional | PDF ↗ |
| K002660 | HARDYDISK LOMEFLOXACIN, 10MCG | Hardy Diagnostics | 2000-10-26 | Traditional | PDF ↗ |
| K002664 | HARDYDISK LEVOFLOXACIN, 5MCG | Hardy Diagnostics | 2000-10-26 | Traditional | PDF ↗ |
| K002367 | HARDY DISK CEFTIZOXIME, 30MCG | Hardy Diagnostics | 2000-10-26 | Traditional | PDF ↗ |
| K002656 | HARDYDISK CEFUROXIME, 30MCG | Hardy Diagnostics | 2000-10-25 | Traditional | PDF ↗ |
| K002368 | HARDYDISK STREPTOMYCIN, 300MCG | Hardy Diagnostics | 2000-10-25 | Traditional | PDF ↗ |
| K002663 | HARDYDISK NETILMICIN, 30MCG | Hardy Diagnostics | 2000-10-19 | Traditional | PDF ↗ |
| K002165 | LINEZOLID, 30UG, BBL SENSI-DISC | Dickinson, and Co. | 2000-09-05 | Traditional | PDF ↗ |
| K001728 | HARDY DISK CLARITHROMYCIN, 15MCG | Hardy Diagnostics | 2000-07-27 | Traditional | PDF ↗ |
| K001487 | HARDYDISK CINOXACIN, 100 MCG | Hardy Diagnostics | 2000-06-07 | Traditional | PDF ↗ |
| K001490 | HARDYDISK CEFONICID, 30 MCG | Hardy Diagnostics | 2000-06-01 | Traditional | PDF ↗ |
| K001489 | HARDYDISK CEFOPERAZONE, 75 MCG | Hardy Diagnostics | 2000-06-01 | Traditional | PDF ↗ |
| K000930 | GATIFLOXACIN ANTIMICROBIAL SUSCEPTIBILITY TEST DISC | Oxoid , Ltd. | 2000-05-22 | Traditional | PDF ↗ |
| K000928 | QUINUPRISTIN/DALFOPRISTIN ANTIMICROBIAL SUSCEPTIBILITY TEST DISC | Oxoid , Ltd. | 2000-05-15 | Traditional | PDF ↗ |
| K000762 | MOXIFLOXACIN, 5 UG, BBL SENSI-DISC | Bd Becton Dickinson Vacutainer Systems Preanalytic | 2000-04-25 | Traditional | PDF ↗ |
| K000829 | GATIFLOXACIN, 5 UG, BBL SENSI-DISC | Bd Becton Dickinson Vacutainer Systems Preanalytic | 2000-04-13 | Traditional | PDF ↗ |
| K000526 | HARDYDISK, CEPHALOTHIN 30MCG | Hardy Diagnostics | 2000-04-13 | Traditional | PDF ↗ |
| K000268 | HARDYDISK, AMPICILLIN, 10MCG | Hardy Diagnostics | 2000-04-07 | Traditional | PDF ↗ |
| K000509 | HARDYDISK, VANCOMYCIN 30MCG | Hardy Diagnostics | 2000-04-07 | Traditional | PDF ↗ |
| K000440 | HARDYDISK CEFTRIAXONE 30MCG | Hardy Diagnostics | 2000-04-07 | Traditional | PDF ↗ |
| K000272 | HARDYDISK, NITROFURANTOIN | Hardy Diagnostics | 2000-04-07 | Traditional | PDF ↗ |
| K000261 | HARDYDISK, PIPERACILLIN/TAZOBACTAM, 110MCG | Hardy Diagnostics | 2000-04-07 | Traditional | PDF ↗ |
| K000524 | HARDYDISK, CEFOTAXIME 30MCG | Hardy Diagnostics | 2000-04-07 | Traditional | PDF ↗ |
| K000525 | HARDYDISK OFLOXACIN 5MCG | Hardy Diagnostics | 2000-04-07 | Traditional | PDF ↗ |
| K000271 | HARDYDISK, SULFA/TRIMETH | Hardy Diagnostics | 2000-04-07 | Traditional | PDF ↗ |
| K000305 | HARDYDISK, CEFOXITIN, 30MCG | Hardy Diagnostics | 2000-03-31 | Traditional | PDF ↗ |
| K000304 | HARDYDISK, TETRACYCLINE 30MCG | Hardy Diagnostics | 2000-03-29 | Traditional | PDF ↗ |
| K000302 | HARDY DISK, PENICILLIN, 10 UNITS | Hardy Diagnostics | 2000-03-24 | Traditional | PDF ↗ |
| K000259 | HARDYDISK, CEFTAZIDIME, 30MCG | Hardy Diagnostics | 2000-03-21 | Traditional | PDF ↗ |
| K000203 | HARDYDISK, KANAMYCIN, 30MCG | Hardy Diagnostics | 2000-03-21 | Traditional | PDF ↗ |
| K000258 | HARDYDISK, CIPROFLOXACIN, 5MCG | Hardy Diagnostics | 2000-03-21 | Traditional | PDF ↗ |
| K000181 | HARDYDISK, CARBENICILLIN, 100MCG | Hardy Diagnostics | 2000-03-02 | Traditional | PDF ↗ |
| K000175 | HARDYDISK TICARILLIN 75MCG | Hardy Diagnostics | 2000-03-02 | Traditional | PDF ↗ |
| K000130 | HARDYDISK, NALIDIXIC ACID, 30MCG | Hardy Diagnostics | 2000-02-29 | Traditional | PDF ↗ |
| K000182 | HARDYDISK TOBRAMYCIN, 10MCG | Hardy Diagnostics | 2000-02-29 | Traditional | PDF ↗ |
Product code JTN · Class II · Microbiology. Data: openFDA.