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
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
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
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
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
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
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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