FDA 510(k) Applications for Medical Device Product Code "JTN"
(Susceptibility Test Discs, Antimicrobial)
| FDA 510(k) Number | Applicant | Device Name | Decision Date |
| K961188 | BD BECTON DICKINSON VACUTAINER SYSTEMS PREANALYTIC | CEFEPIME, 30 MCG, SENSI-DISC | 04/05/1996 |
| K000829 | BD BECTON DICKINSON VACUTAINER SYSTEMS PREANALYTIC | GATIFLOXACIN, 5 UG, BBL SENSI-DISC | 04/13/2000 |
| K000762 | BD BECTON DICKINSON VACUTAINER SYSTEMS PREANALYTIC | MOXIFLOXACIN, 5 UG, BBL SENSI-DISC | 04/25/2000 |
| K993186 | BD BECTON DICKINSON VACUTAINER SYSTEMS PREANALYTIC | SYNERCID, 15 UG, BBL SENSI-DISC | 11/03/1999 |
| K080998 | BECTON DICKINSON & CO. | DORIPENEM 10UG BBL SENSI-DISC | 05/12/2008 |
| K020842 | BECTON DICKINSON & CO. | ERTAPENEM 10UG BBL SENSI-DISC | 05/15/2002 |
| K082271 | BECTON DICKINSON & CO. | FLUCONAZOLE 25UG BBL SENSI-DISC | 10/06/2008 |
| K050062 | BECTON DICKINSON & CO. | GEMIFLOXACIN, 5UG BBL SENSI-DISC | 02/10/2005 |
| K052876 | BECTON DICKINSON & CO. | TELITHROMYCIN 15UG BBL SENSI-DISC | 11/14/2005 |
| K052853 | BECTON DICKINSON & CO. | TIGECYCLINE 15UG BBL SENSI-DISC | 11/17/2005 |
| K082272 | BECTON DICKINSON & CO. | VORICONAZOLE 1UG BBL SENSI-DISC | 10/02/2008 |
| K112586 | BECTON DICKINSON AND COMPANY (BD) | CEFTAROLINE 30 MICROGRAMS, BBL(TM) SENSI-DISC(TM) | 10/18/2011 |
| K981517 | BECTON DICKINSON MICROBIOLOGY SYSTEMS | CEFDINIR, 5 UG, SENSI-DISC | 06/09/1998 |
| K993577 | BECTON DICKINSON MICROBIOLOGY SYSTEMS | CEFOTAXIME/CLAVULANIC, 30/10UG, BBL SENSI-DISC AND CEFTAZIDIME/CLAVULANIC ACID, 30/10UG, BBL SENSI-DISC | 12/01/1999 |
| K965159 | BECTON DICKINSON MICROBIOLOGY SYSTEMS | CETIBUTEN, 30MCG, SENSI-DISC | 02/04/1997 |
| K972098 | BECTON DICKINSON MICROBIOLOGY SYSTEMS | FOSFOMYCIN, 200 MG, SENSI-DISC | 07/28/1997 |
| K974578 | BECTON DICKINSON MICROBIOLOGY SYSTEMS | GREPAFLOXACIN, 5 MG, SENSI-DISC | 02/23/1998 |
| K970212 | BECTON DICKINSON MICROBIOLOGY SYSTEMS | LEVOFLOXACIN, 5MCG, SENSI-DISC | 03/06/1997 |
| K963845 | BECTON DICKINSON MICROBIOLOGY SYSTEMS | MEROPENEM, 10 MCG, SENSI-DISC | 10/25/1996 |
| K970385 | BECTON DICKINSON MICROBIOLOGY SYSTEMS | SPARFLOZACIN, 5 MCG, SENSI-DISC | 03/10/1997 |
| K980683 | BECTON DICKINSON MICROBIOLOGY SYSTEMS | TROVAFLOXACIN 10G, SENSI-DISC | 05/01/1998 |
| K221826 | Becton Dickinson, and Company | BD BBL Sensi-Disc Cefiderocol 30ug (FDC-30) | 12/21/2022 |
| K152516 | BECTON, DICKINSON AND COMPANY | BD BBL Sensi-Disc Ceftazidime Avibactam (30/20ug), Antimicrobial Susceptibility Test Disks | 10/13/2015 |
| K230651 | Becton, Dickinson and Company | BD BBLÖ Sensi-DiscÖ Lefamulin 20╡g (LMU-20) | 06/07/2023 |
| K100722 | Becton, Dickinson and Company | TELAVANCIN 30 UG, BBL SENSI-DISC | 03/29/2010 |
| K002165 | DICKINSON, AND CO. | LINEZOLID, 30UG, BBL SENSI-DISC | 09/05/2000 |
| K971120 | DIFCO LABORATORIES, INC. | DISPENS-O-DISC (TM) LEVOFLOXACIN | 04/14/1997 |
| K963508 | DIFCO LABORATORIES, INC. | DISPENS-O-DISC MEROPENEM | 09/26/1996 |
| K971211 | DIFCO LABORATORIES, INC. | DISPENS-O-DISC SPARFLOXACIN | 04/14/1997 |
| K011385 | HARDY DIAGNOSTICS | HARDKYDISK NEOMYCIN, 30 MCG | 05/18/2001 |
| K994067 | HARDY DIAGNOSTICS | HARDY DISK AMPICILLIN/SULBACTAM | 01/14/2000 |
| K062245 | HARDY DIAGNOSTICS | HARDY DISK AST TIGECYCLINE 15 UG, MODELZ936 | 08/23/2006 |
| K002367 | HARDY DIAGNOSTICS | HARDY DISK CEFTIZOXIME, 30MCG | 10/26/2000 |
| K001728 | HARDY DIAGNOSTICS | HARDY DISK CLARITHROMYCIN, 15MCG | 07/27/2000 |
| K003532 | HARDY DIAGNOSTICS | HARDY DISK, CEFPODOXINE, 10MCG | 12/13/2000 |
| K000302 | HARDY DIAGNOSTICS | HARDY DISK, PENICILLIN, 10 UNITS | 03/24/2000 |
| K993993 | HARDY DIAGNOSTICS | HARDYDISK AMIKACIN 30MCG | 12/27/1999 |
| K003556 | HARDY DIAGNOSTICS | HARDYDISK AMOXICILLIN/CLAVULANIC ACID, 20/10MCG | 01/17/2001 |
| K241060 | Hardy Diagnostics | HardyDisk AST Cefiderocol 30╡g (FDC30) | 07/18/2024 |
| K193504 | Hardy Diagnostics | HardyDisk AST Cefiderocol 30ug (FDC30) | 01/23/2020 |
| K103538 | HARDY DIAGNOSTICS | HARDYDISK AST CEFTAROLINE, 30 UG MODEL Z939 | 12/17/2010 |
| K152838 | HARDY DIAGNOSTICS | HardyDisk AST Ceftazidime/Avibactam, (30/20ug)-CZA50 | 11/24/2015 |
| K152846 | HARDY DIAGNOSTICS | HardyDisk AST Ceftolozane/Tazobactam, (30/10ug)- C/T40 | 11/24/2015 |
| K171975 | Hardy Diagnostics | HardyDisk AST Delafloxacin 5 ╡g (DLX5) | 08/01/2017 |
| K080019 | HARDY DIAGNOSTICS | HARDYDISK AST DORIPENEM 10 UG | 01/29/2008 |
| K182357 | Hardy Diagnostics | HardyDisk AST Eravacycline 20╡g (ERV20) | 09/26/2018 |
| K250956 | Hardy Diagnostics | HardyDisk AST Gepotidacin 10╡g (GEP10) | 06/26/2025 |
| K191931 | Hardy Diagnostics | HardyDisk AST Imipenem/relebactam 10/25╡g (IMR10/25) | 07/31/2019 |
| K192326 | Hardy Diagnostics | HardyDisk AST Lefamulin 20╡g (LMU20) | 09/19/2019 |
| K183298 | Hardy Diagnostics | HardyDisk AST Omadacycline 30╡g (OMC30) | 01/18/2019 |
| K181700 | Hardy Diagnostics | HardyDisk AST Plazomicin 30ug (PLZ30) | 07/10/2018 |
| K230827 | Hardy Diagnostics | HardyDisk AST Rezafungin 5╡g (RZF5) | 06/01/2023 |
| K231568 | Hardy Diagnostics | HardyDisk AST Sulbactam/Durlobactam 10/10╡g (SUD20) | 07/06/2023 |
| K093807 | HARDY DIAGNOSTICS | HARDYDISK AST TELAVANCIN,30UG | 01/08/2010 |
| K993994 | HARDY DIAGNOSTICS | HARDYDISK AZITHROMYCIN 15MCG | 12/21/1999 |
| K994063 | HARDY DIAGNOSTICS | HARDYDISK AZTREONAM, 30MCG | 01/14/2000 |
| K250454 | Hardy Diagnostics | HardyDisk Aztreonam/Avibactam 30/20╡g (AZA50) | 05/15/2025 |
| K011086 | HARDY DIAGNOSTICS | HARDYDISK BACITRACIN, 10MCG, MODEL Z927 | 04/26/2001 |
| K994046 | HARDY DIAGNOSTICS | HARDYDISK CEFACLOR 30MCG | 02/01/2000 |
| K000022 | HARDY DIAGNOSTICS | HARDYDISK CEFAMANDOLE, 30MCG | 02/17/2000 |
| K994129 | HARDY DIAGNOSTICS | HARDYDISK CEFIXIME, 5MCG | 02/11/2000 |
| K001490 | HARDY DIAGNOSTICS | HARDYDISK CEFONICID, 30 MCG | 06/01/2000 |
| K001489 | HARDY DIAGNOSTICS | HARDYDISK CEFOPERAZONE, 75 MCG | 06/01/2000 |
| K002661 | HARDY DIAGNOSTICS | HARDYDISK CEFOTETAN, 30MCG | 10/26/2000 |
| K170127 | Hardy Diagnostics | HardyDisk Ceftolozane/Tazobactam, (30/10 ug)-C/T40 | 03/14/2017 |
| K000440 | HARDY DIAGNOSTICS | HARDYDISK CEFTRIAXONE 30MCG | 04/07/2000 |
| K002656 | HARDY DIAGNOSTICS | HARDYDISK CEFUROXIME, 30MCG | 10/25/2000 |
| K994089 | HARDY DIAGNOSTICS | HARDYDISK CHLORAMPHENICOL, 30MCG | 02/11/2000 |
| K001487 | HARDY DIAGNOSTICS | HARDYDISK CINOXACIN, 100 MCG | 06/07/2000 |
| K002662 | HARDY DIAGNOSTICS | HARDYDISK CLINDAMYCIN, 2MCG | 11/02/2000 |
| K994051 | HARDY DIAGNOSTICS | HARDYDISK DOXYCYCLINE, 30MCG | 01/10/2000 |
| K994135 | HARDY DIAGNOSTICS | HARDYDISK ERYTHROMYCIN, 15MCG | 02/16/2000 |
| K994091 | HARDY DIAGNOSTICS | HARDYDISK GENTAMICIN, 10MCG | 02/11/2000 |
| K002369 | HARDY DIAGNOSTICS | HARDYDISK GENTAMICIN, 120MCG | 10/26/2000 |
| K994132 | HARDY DIAGNOSTICS | HARDYDISK IMIPENEM, 10MCG | 01/18/2000 |
| K002664 | HARDY DIAGNOSTICS | HARDYDISK LEVOFLOXACIN, 5MCG | 10/26/2000 |
| K002660 | HARDY DIAGNOSTICS | HARDYDISK LOMEFLOXACIN, 10MCG | 10/26/2000 |
| K172621 | Hardy Diagnostics | HardyDisk Meropenem/Vaborbactam 20/10╡g (MEV30) | 10/03/2017 |
| K994212 | HARDY DIAGNOSTICS | HARDYDISK MEZLOCILLIN 75MCG | 02/15/2000 |
| K003536 | HARDY DIAGNOSTICS | HARDYDISK NAFCILLIN, 1 MCG | 01/12/2001 |
| K002663 | HARDY DIAGNOSTICS | HARDYDISK NETILMICIN, 30MCG | 10/19/2000 |
| K994150 | HARDY DIAGNOSTICS | HARDYDISK NORFLOXACIN, 10MCG | 02/16/2000 |
| K011384 | HARDY DIAGNOSTICS | HARDYDISK NOVOBIOCIN, 30MCG, MODEL Z883 | 06/13/2001 |
| K000525 | HARDY DIAGNOSTICS | HARDYDISK OFLOXACIN 5MCG | 04/07/2000 |
| K994134 | HARDY DIAGNOSTICS | HARDYDISK OXACILLIN, 1MCG | 02/17/2000 |
| K003537 | HARDY DIAGNOSTICS | HARDYDISK RIFAMPIN, 5MCG | 01/12/2001 |
| K002368 | HARDY DIAGNOSTICS | HARDYDISK STREPTOMYCIN, 300MCG | 10/25/2000 |
| K003690 | HARDY DIAGNOSTICS | HARDYDISK SULFISOXAZOLE | 01/25/2001 |
| K003686 | HARDY DIAGNOSTICS | HARDYDISK TICARCILLIN/CLAVULANIC ACID, 85MCG | 01/12/2001 |
| K000175 | HARDY DIAGNOSTICS | HARDYDISK TICARILLIN 75MCG | 03/02/2000 |
| K000182 | HARDY DIAGNOSTICS | HARDYDISK TOBRAMYCIN, 10MCG | 02/29/2000 |
| K003554 | HARDY DIAGNOSTICS | HARDYDISK TRIMETHOPRIM 5MCG | 01/19/2001 |
| K000268 | HARDY DIAGNOSTICS | HARDYDISK, AMPICILLIN, 10MCG | 04/07/2000 |
| K000181 | HARDY DIAGNOSTICS | HARDYDISK, CARBENICILLIN, 100MCG | 03/02/2000 |
| K000128 | HARDY DIAGNOSTICS | HARDYDISK, CEFAZOLIN, 30MCG | 02/18/2000 |
| K000524 | HARDY DIAGNOSTICS | HARDYDISK, CEFOTAXIME 30MCG | 04/07/2000 |
| K000305 | HARDY DIAGNOSTICS | HARDYDISK, CEFOXITIN, 30MCG | 03/31/2000 |
| K000259 | HARDY DIAGNOSTICS | HARDYDISK, CEFTAZIDIME, 30MCG | 03/21/2000 |
| K000526 | HARDY DIAGNOSTICS | HARDYDISK, CEPHALOTHIN 30MCG | 04/13/2000 |
| K000258 | HARDY DIAGNOSTICS | HARDYDISK, CIPROFLOXACIN, 5MCG | 03/21/2000 |
| K000203 | HARDY DIAGNOSTICS | HARDYDISK, KANAMYCIN, 30MCG | 03/21/2000 |
| K000130 | HARDY DIAGNOSTICS | HARDYDISK, NALIDIXIC ACID, 30MCG | 02/29/2000 |
| K000272 | HARDY DIAGNOSTICS | HARDYDISK, NITROFURANTOIN | 04/07/2000 |
| K000183 | HARDY DIAGNOSTICS | HARDYDISK, PIPERACILLIN, 100MCG | 02/28/2000 |
| K000261 | HARDY DIAGNOSTICS | HARDYDISK, PIPERACILLIN/TAZOBACTAM, 110MCG | 04/07/2000 |
| K000201 | HARDY DIAGNOSTICS | HARDYDISK, STREPTOMYCIN 10MCG | 02/29/2000 |
| K000271 | HARDY DIAGNOSTICS | HARDYDISK, SULFA/TRIMETH | 04/07/2000 |
| K000304 | HARDY DIAGNOSTICS | HARDYDISK, TETRACYCLINE 30MCG | 03/29/2000 |
| K000509 | HARDY DIAGNOSTICS | HARDYDISK, VANCOMYCIN 30MCG | 04/07/2000 |
| K250885 | Liofilchem Inc. | Ceftobiprole BPR 5 ╡g Disc | 06/23/2025 |
| K203700 | Oxoid Limited (Part of Thermo Fisher Scientific) | Thermo Scientific Oxoid Cefiderocol Disc (30 ╡g) FDC30 | 07/30/2021 |
| K193508 | Oxoid Limited (Part of Thermo Fisher Scientific) | Thermo Scientific Oxoid Eravacycline Disc (20ug) ERV20 | 12/04/2020 |
| K210873 | Oxoid Limited (part of Thermo Fisher Scientific) | Thermo Scientific Oxoid Lefamulin Disc (20╡g) LMU20 | 10/27/2021 |
| K181975 | Oxoid Limited (Part of Thermo Fisher Scientific) | Thermo Scientific Oxoid Meropenem/Vaborbactam Disc (30╡g) MEV30 | 09/27/2018 |
| K203336 | Oxoid Limited (part of Thermo Fisher Scientific) | Thermo Scientific Oxoid Omadacycline Disc (30 ug) OMC30 | 09/15/2022 |
| K231806 | Oxoid Limited (Part of Thermo Fisher Scientific) | Thermo Scientific Oxoid Rezafungin Disc (5 ╡g) RZF5 | 03/22/2024 |
| K232276 | Oxoid Limited (Part of Thermo Fisher Scientific) | Thermo Scientific Oxoid Sulbactam/Durlobactam Disc (10/10 ╡g) SUD20 | 10/06/2023 |
| K982524 | OXOID, LTD. | AMOXICILLIN/CLAVULANIC ACID ANTIMICROBIAL SUSCEPTIBILITY TEST DISC | 09/09/1998 |
| K971635 | OXOID, LTD. | AZITHROMYCIN ANTIMICROBIAL SUSCEPTIBILITY TEST DISC | 07/03/1997 |
| K973479 | OXOID, LTD. | CEFMETAZOLE ANTIMICROBIAL SUSCEPTIBILITY TEST DISC | 12/01/1997 |
| K982520 | OXOID, LTD. | CEFONICID ANTIMICROBIAL SUSCEPTIBILITY TEST DISC | 09/09/1998 |
| K971631 | OXOID, LTD. | CEFOTETAN ANTIMICROBIAL SUSCEPTIBILITY TEST DISC | 07/03/1997 |
| K973487 | OXOID, LTD. | CEFPODOXIME ANTIMICROBIAL SUSCEPTIBILITY TEST DISC | 10/06/1997 |
| K982517 | OXOID, LTD. | CEFPROZIL ANTIMICROBIAL SUSCEPTIBILITY TEST DISC | 09/09/1998 |
| K971638 | OXOID, LTD. | CLARITHROMYCIN ANTIMICROBIAL SUSCEPTIBILITY TEST DISC | 08/20/1997 |
| K971637 | OXOID, LTD. | COMPOUND SULPHONAMIDES ANTIMICROBIAL SUSCEPTIBILITY TEST DISC | 12/23/1997 |
| K042157 | OXOID, LTD. | DAPTOMYCIN ANTIMICROBIAL SUSCEPTIBILITY TEST DISC | 09/14/2004 |
| K974394 | OXOID, LTD. | ENOXACIN ANTIMICROBIAL SUSCEPTIBILITY TEST DISC | 01/14/1998 |
| K070262 | OXOID, LTD. | ERTAPENEM ANTIMICROBIAL SUSCEPTIBILITY TEST DISC | 03/14/2007 |
| K000930 | OXOID, LTD. | GATIFLOXACIN ANTIMICROBIAL SUSCEPTIBILITY TEST DISC | 05/22/2000 |
| K984608 | OXOID, LTD. | GENTAMICIN ANTIMICROBIAL SUSCEPTIBILITY TEST DISC | 03/09/1999 |
| K982519 | OXOID, LTD. | LEVOFLOXACIN ANTIMICROBIAL SUSCEPTIBILITY TEST DISC | 09/09/1998 |
| K010537 | OXOID, LTD. | LINEZOLID ANTIMICROBIAL SUSCEPTIBILITY TEST DISC | 04/24/2001 |
| K973488 | OXOID, LTD. | LOMEFLOXACIN ANTIMICROBIAL SUSCEPTIBILITY TEST DISC | 10/10/1997 |
| K973489 | OXOID, LTD. | LORACARBEF ANTIMICROBIAL SUSCEPTIBILITY TEST DISC | 10/10/1997 |
| K983718 | OXOID, LTD. | MEROPENEM ANTIMICROBIAL SUSCEPTIBILITY TEST DISC | 12/11/1998 |
| K010536 | OXOID, LTD. | MOXIFLOXACIN ANTIMICROBIAL SUSCEPTIBILITY TEST DISC | 04/24/2001 |
| K982528 | OXOID, LTD. | NAFCILLIN ANTIMICROBIAL SUSCEPTIBILITY TEST DISC | 09/09/1998 |
| K984036 | OXOID, LTD. | NETILMICIN ANTIMICROBIAL SUSCEPTIBILITY TEST DISC | 01/13/1999 |
| K982669 | OXOID, LTD. | OXOID STREPTOMYCIN ANTIMICROBIAL SUSCEPTIBILITY TEST DISC | 09/09/1998 |
| K971633 | OXOID, LTD. | PIPERACILLIN/TAZOBACTAM ANTIMICROBIAL SUSCEPTIBILITY TEST DISC | 07/03/1997 |
| K000928 | OXOID, LTD. | QUINUPRISTIN/DALFOPRISTIN ANTIMICROBIAL SUSCEPTIBILITY TEST DISC | 05/15/2000 |
| K971636 | OXOID, LTD. | RIFAMPICIN ANTIMICROBIAL SUSCEPTIBILITY TEST DISC | 01/28/1998 |
| K982526 | OXOID, LTD. | SPARFLOXACIN ANTIMICROBIAL SUSCEPTIBILITY TEST DISC | 09/09/1998 |
| K982523 | OXOID, LTD. | SULFISOXAZOLE ANTIMICROBIAL SUSCEPTIBILITY TEST DISC | 09/09/1998 |
| K971632 | OXOID, LTD. | TICARCILLIN/CLAVULANIC ACID ANTIMICROBIAL SUSCEPTIBILITY TEST DISC | 08/13/1997 |
| K060286 | OXOID, LTD. | TIGECYCLINE ANTIMICROBIAL SUSCEPTIBILITY TEST DISC | 03/17/2006 |
| K984513 | OXOID, LTD. | TROVAFLOXACIN ANTIMICROBIAL SUSCEPTIBILITY TEST DISC | 04/02/1999 |
| K992420 | PASCO LABORATORIES, INC. | MODIFICATION OF PASCO MIC AND MIC/ID PANELS | 09/27/1999 |
| K980955 | PASCO LABORATORIES, INC. | PASCO MIC AND MIC/ID PANELS | 05/18/1998 |
| K982235 | PASCO LABORATORIES, INC. | PASCO MIC AND MIC/ID PANELS | 07/30/1998 |
| K992076 | PASCO LABORATORIES, INC. | PASCO MIC AND MIC/ID PANELS (CEFUROXIME) | 08/30/1999 |
| K992077 | PASCO LABORATORIES, INC. | PASCO MIC AND MIC/ID PANELS (OFLOXACIN) | 09/03/1999 |
| K992853 | PASCO LABORATORIES, INC. | PASCO MIC AND MIC/ID PANELS, CEFDINIR | 11/04/1999 |
| K992568 | PASCO LABORATORIES, INC. | PASCO MIC AND MIC/ID PANELS, CEFOTAXIME | 10/14/1999 |
| K992562 | PASCO LABORATORIES, INC. | PASCO MIC AND MIC/ID PANELS, CEFTRIAXONE | 10/13/1999 |
| K992593 | PASCO LABORATORIES, INC. | PASCO MIC AND MIC/ID PANELS, CHLORAMPHENICOL | 10/14/1999 |
| K992647 | PASCO LABORATORIES, INC. | PASCO MIC AND MIC/ID PANELS, ERYTHROMYCIN | 10/19/1999 |
| K992297 | PASCO LABORATORIES, INC. | PASCO MIC AND MIC/ID PANELS, LEVOFLOXACIN | 09/03/1999 |
| K992546 | PASCO LABORATORIES, INC. | PASCO MIC AND MIC/ID PANELS, MEROPENEM | 10/12/1999 |
| K992646 | PASCO LABORATORIES, INC. | PASCO MIC AND MIC/ID PANELS, PENICILLIN | 10/19/1999 |
| K992726 | PASCO LABORATORIES, INC. | PASCO MIC AND MIC/ID PANELS, QUINUPRISTIN/DALFOPRISTIN FOR NONFASTIDIOUS ORGANISMS | 11/03/1999 |
| K992507 | PASCO LABORATORIES, INC. | PASCO MIC AND MIC/ID PANELS, TROVAFLOXACIN | 10/08/1999 |
| K992717 | PASCO LABORATORIES, INC. | PASCO MIC AND MIC/ID PANELS,QUINUPRISTIN/DALFOPRISTIN | 11/02/1999 |
| K955669 | REMEL CO. | REMEL CEFEPIME 30 UG SUSCEPTIBILITY DISK | 02/23/1996 |
| K970830 | REMEL, INC. | REMEL LEVOFLOXACIN 5G SUSCEPTIBILTY DISK | 04/02/1997 |
| K970831 | REMEL, INC. | REMEL SPARFLOXACIN 5G SUSCEPTIBILTY DISK | 04/02/1997 |
| K961818 | REMEL, L.P. | GENTAMICIN DISK (120MCG) | 07/10/1996 |
| K964421 | REMEL, L.P. | REMEL MEROPENEM 10UG SUSCEPTIBILITY DISK | 12/06/1996 |
| K961819 | REMEL, L.P. | STREPTOMYCIN DISK (300MCG) | 07/10/1996 |
| K250789 | Thermo Fisher Scientific (Oxoid Ltd.) | Thermo Scientific Oxoid Aztreonam/Avibactam Disc (30/20 ╡g) AZA50 | 06/12/2025 |
| K964490 | UNIPATH LTD. | AZTREONAM ANTIMICROBIAL SUSCEPTIBILITY TEST DISC | 02/07/1997 |
| K964489 | UNIPATH LTD. | CEFACLOR ANTIMICROBIAL SUSCEPTIBILITY TEST DISC | 02/07/1997 |
| K964495 | UNIPATH LTD. | CEFEPINE ANTIMICROBIAL SUSCEPTIBILITY TEST DISC | 02/07/1997 |
| K964496 | UNIPATH LTD. | CEFIXIME ANTIMICROBIAL SUSCEPTIBILTY TEST DISC | 02/06/1997 |
| K964512 | UNIPATH LTD. | CEFTIZOXIME ANTIMICROBIAL SUSCEPTIBILITY TEST DISC | 02/06/1997 |
| K964492 | UNIPATH LTD. | CIPROFLOXACIN ANTIMICROBIAL SUSCEPTIBILITY TEST DISC | 02/07/1997 |
| K964487 | UNIPATH LTD. | IMIPENEM ANTIMICROBIAL SUSCEPTIBILITY TEST DISC | 02/07/1997 |
| K964491 | UNIPATH LTD. | NORFLOXACIN ANTIMICROBIAL SUSCEPTIBILITY TEST DISC | 02/07/1997 |
| K964493 | UNIPATH LTD. | OFLOXACIN ANTIMICROBIAL SUSCEPTIBILITY TEST DISC | 02/06/1997 |
| K964501 | UNIPATH LTD. | SULBACTAM/AMPICILLIN ANTIMICROBIAL SUSCEPTIBILITY TEST DISC | 02/06/1997 |
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