FDA 510(k) Applications for Medical Device Product Code "JWY"
(Manual Antimicrobial Susceptibility Test Systems)
| FDA 510(k) Number | Applicant | Device Name | Decision Date |
| K964236 | AB BIODISK | (MODIFIED) ETEST PACKAGE INSERT | 05/01/1997 |
| K970210 | AB BIODISK | AMIKACIN | 05/01/1997 |
| K042392 | AB BIODISK | DAPTOMYCIN | 12/13/2004 |
| K980335 | AB BIODISK | ETEST BENZYLPENICILLIN | 06/15/1998 |
| K981135 | AB BIODISK | ETEST BENZYLPENICILLIN | 06/09/1998 |
| K980877 | AB BIODISK | ETEST CEFDINIR | 07/06/1998 |
| K021445 | AB BIODISK | ETEST CEFDITOREN FOR S. PNEUMONIAE AND H. INFLUENZAE | 06/06/2002 |
| K981137 | AB BIODISK | ETEST CEFOTAXIME | 06/09/1998 |
| K980345 | AB BIODISK | ETEST CEFTRIAXONE | 05/27/1998 |
| K981139 | AB BIODISK | ETEST CEFTRIAXONE | 06/01/1998 |
| K980342 | AB BIODISK | ETEST CHLORAMPHENICAL | 05/29/1998 |
| K981138 | AB BIODISK | ETEST CIPROFLOXACIN | 06/05/1998 |
| K081325 | AB BIODISK | ETEST DORIPENEM - ANTIMICROBIAL SUSCEPTIBILITY TEST - MIC AT 0.002-32 UG/ML | 07/24/2008 |
| K020748 | AB BIODISK | ETEST ERTAPENEM | 04/29/2002 |
| K001547 | AB BIODISK | ETEST ESBL CT/CTL STRIP; ETEST ESBL TZ/TZL STRIP | 08/07/2000 |
| K962794 | AB BIODISK | ETEST FOR AZTREONAM | 08/30/1996 |
| K963107 | AB BIODISK | ETEST FOR CEFEPIME | 10/24/1996 |
| K971694 | AB BIODISK | ETEST FOR CEFTAZIDIME | 06/30/1997 |
| K990722 | AB BIODISK | ETEST FOR CEFUROXIME | 04/22/1999 |
| K042390 | AB BIODISK | ETEST FOR GEMIFLOXACIN | 11/19/2004 |
| K971697 | AB BIODISK | ETEST FOR LEVOFLOXACIN | 07/14/1997 |
| K981136 | AB BIODISK | ETEST FOSFOMYCIN | 06/09/1998 |
| K000596 | AB BIODISK | ETEST GATIFLOXACIN | 05/22/2000 |
| K980773 | AB BIODISK | ETEST GREPAFLOXACIN | 05/18/1998 |
| K010363 | AB BIODISK | ETEST MEROPENEM | 04/09/2001 |
| K990297 | AB BIODISK | ETEST MINOCYCLINE | 03/22/1999 |
| K000298 | AB BIODISK | ETEST MOXIFLOXACIN | 05/18/2000 |
| K980338 | AB BIODISK | ETEST OFLOXACIN | 05/28/1998 |
| K982868 | AB BIODISK | ETEST RIFAMPICIN WITH INDICATIONS FOR S. PNEUMONIAE | 09/30/1998 |
| K970820 | AB BIODISK | ETEST SPARFLOXACIN | 04/25/1997 |
| K960991 | AB BIODISK | ETEST SUBMISSION FOR AMOXICILLIN | 10/08/1996 |
| K961519 | AB BIODISK | ETEST SUBMISSION FOR AZITHROMYCIN | 07/05/1996 |
| K970473 | AB BIODISK | ETEST SUBMISSION FOR AZITHROMYCIN/S. PNEUMONIAE | 05/01/1997 |
| K961517 | AB BIODISK | ETEST SUBMISSION FOR CEFOTETAN | 07/05/1996 |
| K960989 | AB BIODISK | ETEST SUBMISSION FOR IMIPENEM | 05/20/1996 |
| K960990 | AB BIODISK | ETEST SUBMISSION FOR VANCOMYCIN | 05/20/1996 |
| K980347 | AB BIODISK | ETEST TETRACYCLINE | 05/27/1998 |
| K981134 | AB BIODISK | ETEST TETRACYCLINE | 05/28/1998 |
| K052366 | AB BIODISK | ETEST TIGECYCLINE GRAM POSITIVE AND GRAM NEGATIVE AEROBIC BACTERIA, STREPTOCOCCUS SPP. AND ANAEROBIC BACTERIA | 10/13/2005 |
| K980603 | AB BIODISK | ETEST TROVAFLOXACIN | 05/13/1998 |
| K980348 | AB BIODISK | ETEST VANCOMYCIN | 05/29/1998 |
| K964203 | AB BIODISK | PIPERACILLIN/TAZOBACTAM 4 | 12/18/1996 |
| K983890 | AB BIODISK | SYSTEM U3 | 02/18/1999 |
| K984144 | AB BIODISK | SYSTEM U3 FOR AMOXICILLIN/CLAVULANIC ACID | 02/09/1999 |
| K984087 | AB BIODISK | SYSTEM U3 FOR AMPICILLIN | 02/08/1999 |
| K984491 | AB BIODISK | SYSTEM U3 FOR CEFUROXIME | 03/09/1999 |
| K984581 | AB BIODISK | SYSTEM U3 FOR CEPHALOTHIN | 03/09/1999 |
| K981639 | AB BIODISK | SYSTEM U3 FOR CIPROFLOXACIN | 09/03/1998 |
| K983565 | AB BIODISK | SYSTEM U3 FOR NITROFURANTOIN | 01/05/1999 |
| K983486 | AB BIODISK | SYSTEM U3 FOR NORFLOXACIN | 12/23/1998 |
| K983571 | AB BIODISK | SYSTEM U3 FOR TETRACYCLINE | 12/30/1998 |
| K983259 | AB BIODISK | SYSTEM U3 FOR TRIMETHOPRIM/SULFAMETHOXAZOLE | 11/25/1998 |
| K955920 | AB BIODISK | THE E TEST CEFTIZOXIME | 02/22/1996 |
| K983027 | AB BIODISK | TRIMETHOPRIM/SULPHAMETHOXAZOLE | 10/02/1998 |
| K990685 | AB BIODISK | TRIMETHOPRIM/SULPHAMETHOXAZOLE (1/19) | 03/26/1999 |
| K983252 | AB BIODISK NORTH AMERICA, INC. | SYSTEM U3 FOR GENTAMICIN | 11/20/1998 |
| K093604 | AB BIOMERIEUX | ETEST MOXIFLOXACIN 0.002-32 UG/ML | 08/25/2010 |
| K960235 | ACCUMED INTL., INC. | SENSITITRE 18 HOUR SUSCEPTIBILITY PLATES | 03/27/1996 |
| K984489 | ACCUMED INTL., INC. | SENSITITRE 18-24 HOUR SUSCEPTIBILITY PLATES | 02/16/1999 |
| K983301 | ACCUMED INTL., INC. | SENSITITRE 18-24 HOUR SUSCEPTIBILITY PLATES WITH TROVAFLOXACIN | 11/25/1998 |
| K965190 | ACCUMED INTL., INC. | SENSITITRE HAEMOPHILUS/STREPTOCOCCUS PNEUMONIAE MIC PLATE | 03/19/1997 |
| K032259 | BD DIAGNOSTIC SYSTEMS | PASCO MIC AND MIC/ID PANELS | 08/19/2003 |
| K032518 | BD DIAGNOSTIC SYSTEMS | PASCO MIC AND MIC/ID PANELS, GEMIFLOXACIN (STREP) | 09/15/2003 |
| K190109 | Beckman Coulter, Inc. | MicroScan Dried Gram Negative MIC/Combo Panels with Eravacycline (ERV) (0.016-32 ug/mL) | 04/18/2019 |
| K192355 | Beckman Coulter, Inc. | MicroScan Dried Gram Negative MIC/Combo Panels with Meropenem (Mer) (0.004-32ug/mL) | 11/14/2019 |
| K152346 | BECKMAN COULTER, INC. | MicroScan Dried Gram Positive MIC/Combo Panels - Vancomycin (0.25-64 ug/mL) | 09/16/2015 |
| K202423 | Beckman Coulter, Inc. | MicroScan MICroSTREP plus Panels with Tetracycline (0.06-16 ╡g/mL) | 05/18/2021 |
| K102668 | BIOMERIEUX | ETEST TOBRAMYCIN 0.016-256 UG/ML AND 0.064-1024 UG/ML | 11/17/2010 |
| K151873 | BIOMERIEUX SA | Etest Ceftaroline (0.002 - 32ug/ml) | 10/07/2015 |
| K192738 | BioMerieux SA | ETEST Delafloxacin (DFX) (0.002-32 ╡g/mL) | 11/26/2019 |
| K192050 | bioMerieux SA | ETEST Eravacycline (ERV) (0.002 û 32 ╡g/mL) | 09/27/2019 |
| K210757 | bioMerieux SA | ETEST Fosfomycin (FO) (0.032-512 ╡g/mL) | 11/12/2021 |
| K191953 | BioMerieux SA | ETEST Imipenem/Relebactam (IPR) (0.002/4-32/4 ug/mL) | 08/22/2019 |
| K183031 | bioMerieux SA | ETEST Meropenem/Vaborbactam (MEV) (0.004/8-64/8 ╡g/mL) | 01/11/2019 |
| K190154 | bioMerieux SA | ETEST Piperacillin/Tazobactam (P/T) (0.016/4-256/4 ug/mL) | 05/01/2019 |
| K180936 | bioMerieux SA | ETEST Telavancin (TLA) (0.002-32 ug/mL) | 07/03/2018 |
| K102535 | BIOMERIEUX SA | ETEST TELAVANCIN IN 0.002-32 UG/ML AND 0.016-256 UG/ML | 05/16/2011 |
| K172150 | bioMerieux, Inc | Etest Ceftazidime/Avibactam (CZA) (0.016 - 256 ug/mL) | 09/15/2017 |
| K121002 | BIOMERIEUX, INC. | ETEST CEFTAROLINE | 10/12/2012 |
| K170670 | bioMerieux, Inc. | Etest Ceftolozane/ Tazobactam (0.016-256 ug/ml) | 05/31/2017 |
| K232395 | bioMΘrieux | ETEST« Sulbactam/Durlobactam (SUD) (0.004/4-64/4 ╡g/mL), ETEST« SUD | 10/05/2023 |
| K200512 | bioMΘrieux S.A. | ETEST Plazomicin (PLZ) (0.016-256 ╡g/mL) | 05/07/2020 |
| K051202 | DADE BEHRING, INC. | DRIED GRAM-POSITIVE MIC/COMBO PANELS | 06/23/2005 |
| K020162 | DADE BEHRING, INC. | DRIED GRAM-POSITIVE MIC/COMBO PANELS WITH PENICILLIN | 03/14/2002 |
| K061536 | DADE BEHRING, INC. | MICROSCAN DRIED GRAM NEGATIVE MIC/COMBO PANELS | 07/18/2006 |
| K061687 | DADE BEHRING, INC. | MICROSCAN DRIED GRAM NEGATIVE MIC/COMBO PANELS | 07/21/2006 |
| K032706 | DADE BEHRING, INC. | MICROSCAN DRIED GRAM-NEGATIVE MIC/COMBO PANELS WITH ERTAPENEM (0.002-32 MCG/ML | 02/10/2004 |
| K020820 | DADE BEHRING, INC. | MICROSCAN MICROSTEP PLUS PANEL NEW ANTIMICROBIAL - CEFUROXIME | 05/09/2002 |
| K020822 | DADE BEHRING, INC. | MICROSCAN MICROSTEP PLUS PANEL NEW ANTIMICROBIAL - VANCOMYCIN | 05/08/2002 |
| K021037 | DADE BEHRING, INC. | MICROSTREP PLUS PANEL WITH AMPICILLIN | 05/06/2002 |
| K970676 | DADE INTL., INC. | DRIED GRAM-NEGATIVE MIC/COMBO PANELS | 05/02/1997 |
| K972524 | DADE INTL., INC. | DRIED GRAM-POSITIVE MIC/COMBO PANELS | 09/08/1997 |
| K020037 | DADE MICROSCAN, INC. | DRIED GRAM NEGATIVE MIC/COMBO PANELS | 03/22/2002 |
| K983408 | DADE MICROSCAN, INC. | DRIED GRAM-NEGATIVE AND GRAM-POSITIVE MIC/COMBO PANELS | 05/10/1999 |
| K983711 | DADE MICROSCAN, INC. | DRIED GRAM-NEGATIVE AND GRAM-POSITIVE MIC/COMBO PANELS | 04/27/1999 |
| K983922 | DADE MICROSCAN, INC. | DRIED GRAM-NEGATIVE AND GRAM-POSITIVE MIC/COMBO PANELS | 06/17/1999 |
| K972180 | DADE MICROSCAN, INC. | DRIED GRAM-NEGATIVE MIC/COMBO PANELS | 08/01/1997 |
| K955910 | DADE MICROSCAN, INC. | DRIED GRAM-NEGATIVE MIC/COMBO PANELS | 02/23/1996 |
| K971376 | DADE MICROSCAN, INC. | DRIED GRAM-NEGATIVE MIC/COMBO PANELS | 05/30/1997 |
| K013423 | DADE MICROSCAN, INC. | MICROSCAN DRIED GRAM NEGATIVE OVERNIGHT MIC/COMBO PANELS | 12/12/2001 |
| K972688 | DADE MICROSCAN, INC. | MICROSCAN DRIED GRAM POSITIVE MIC/COMBO PANELS LEVOFLOXACIN | 09/08/1997 |
| K043589 | DADE MICROSCAN, INC. | MICROSCAN DRIED GRAM-POSITIVE MIC/COMBO PANELS - ERTAPENEM | 02/14/2005 |
| K021018 | DADE MICROSCAN, INC. | MICROSCAN MICROSTREP PLUS PANEL - CHLORAMPHENICOL | 06/11/2002 |
| K021181 | DADE MICROSCAN, INC. | MICROSCAN MICROSTREP PLUS PANEL NEW ANTICROBIAL-CLARITHROMYCIN | 06/17/2002 |
| K020691 | DADE MICROSCAN, INC. | MICROSCAN MICROSTREP PLUS PANEL NEW ANTIMICROBIAL - CEFACLOR | 04/30/2002 |
| K020686 | DADE MICROSCAN, INC. | MICROSCAN MICROSTREP PLUS PANEL NEW ANTIMICROBIAL - TRIMETHOPRIM/SULFAMETHOXAZOLE | 04/30/2002 |
| K021110 | DADE MICROSCAN, INC. | MICROSCAN MICROSTREP PLUS PANEL NEW ANTIMICROBIAL- CEFTRIAXONE | 06/06/2002 |
| K021188 | DADE MICROSCAN, INC. | MICROSCAN MICROSTREP PLUS PANEL NEW ANTIMICROBIAL-CEFEPIME | 06/06/2002 |
| K020556 | DADE MICROSCAN, INC. | MICROSCAN MICROSTREP PLUS PANEL WITH LEVOFLOXACIN | 04/26/2002 |
| K020937 | DADE MICROSCAN, INC. | MICROSCAN MICROSTREP PLUS PANEL-AMOXICILLIN/CLAVULANIC ACID | 05/06/2002 |
| K020938 | DADE MICROSCAN, INC. | MICROSCAN MICROSTREP PLUS PANEL-MEROPENEM | 06/03/2002 |
| K023202 | DADE MICROSCAN, INC. | MICROSCAN SYNERGIES PLUS | 10/23/2002 |
| K983746 | DADE MICROSCAN, INC. | MICROSTREP PLUS PANEL | 12/09/1999 |
| K993679 | DADE MICROSCAN, INC. | MICROSTREP PLUS PANEL - HAEMOPHILUS/AMPICILLIN | 01/14/2000 |
| K021169 | DADE MICROSCAN, INC. | MICROSTREP PLUS PANEL, AZITHROMYCIN | 06/06/2002 |
| K983943 | DADE MICROSCAN, INC. | MICROSTREP PLUS PANEL, LEVOFLOXACIN | 02/18/2000 |
| K983953 | DADE MICROSCAN, INC. | MICROSTREP PLUS PANEL, VANCOMYCIN | 01/14/2000 |
| K963641 | DADE MICROSCAN, INC. | STREPTOCOCCUS MIC PANEL | 12/18/1996 |
| K200308 | Liofilchem s. r. 1. | MTS Lefamulin 0.016- 256 ╡g/mL | 04/06/2020 |
| K163298 | Liofilchem s. r. l. | Liofilchem MIC Test Strip (MTS) Ceftazidime 0.016 - 256.0 ╡g/mL | 02/22/2017 |
| K171906 | Liofilchem s. r. l. | Liofilchem MIC Test Strip (MTS)- Delafloxacin 0.002 - 32 ╡g/mL | 08/01/2017 |
| K180330 | Liofilchem s. r. l. | Liofilchem MIC Test Strip (MTS)- Linezolid 0.016 - 256ug/mL | 03/15/2018 |
| K170892 | Liofilchem s. r. l. | Liofilchem MIC Test Strip (MTS)- Tedizolid 0.002 - 32 ╡g/mL | 05/25/2017 |
| K172542 | Liofilchem s. r. l. | Liofilchem MIC Test Strip (MTS)- Tedizolid 0.002 - 32 mg/mL. | 10/23/2017 |
| K180339 | Liofilchem s. r. l. | Liofilchem MIC Test Strip (MTS), Azithromycin 0.016 - 256 ╡g/mL | 04/04/2018 |
| K173817 | Liofilchem s. r. l. | Liofilchem MIC Test Strip (MTS), Ceftazidime-avibactam 0.016/4 - 256/4 ╡g/mL | 02/28/2018 |
| K180886 | Liofilchem s. r. l. | Liofilchem MIC Test Strip (MTS), Delafloxacin 0.002 - 32 ug/mL | 05/18/2018 |
| K172109 | Liofilchem s. r. l. | Liofilchem MIC Test Strip (MTS), Erythromycin 0.016 - 256 ╡g/mL | 09/27/2017 |
| K173307 | Liofilchem s. r. l. | Liofilchem MIC Test Strip (MTS), Meropenem/vaborbactam 0.016/8 - 256/8 ╡g/mL | 12/19/2017 |
| K192345 | Liofilchem s. r. l. | MTS Ampicillin-Sulbactam 0.016/0.008 - 256/128 ╡g/mL | 10/31/2019 |
| K183527 | Liofilchem s. r. l. | MTS Ciprofloxacin 0.002 - 32 ╡g/mL | 03/19/2019 |
| K190914 | Liofilchem s. r. l. | MTS Doxycycline 0.016 - 256 ╡g/mL | 05/29/2019 |
| K182557 | Liofilchem s. r. l. | MTS Eravacycline 0.002 - 32 ╡g/mL | 11/02/2018 |
| K190252 | Liofilchem s. r. l. | MTS Gentamicin 0.016 - 256 ╡g/mL | 03/22/2019 |
| K191809 | Liofilchem s. r. l. | MTS Imipenem-relebactam 0.002/4-32/4 ╡g/mL | 08/23/2019 |
| K183115 | Liofilchem s. r. l. | MTS Levofloxacin 0.002 - 32 ╡g/mL | 12/20/2018 |
| K200180 | Liofilchem s. r. l. | MTS Omadacycline 0.002 - 32 ug/mL | 03/20/2020 |
| K182922 | Liofilchem s. r. l. | MTS Omadacycline 0.002-32 ╡g/mL | 12/14/2018 |
| K181889 | Liofilchem s. r. l. | MTS Penicillin 0.002- 32 ╡g/mL | 09/13/2018 |
| K211672 | Liofilchem S. R. L. | MTS Piperacillin-tazobactam 0.016/4 - 256/4╡g/mL | 10/20/2021 |
| K181708 | Liofilchem s. r. l. | MTS Plazomicin 0.016-256 ╡g/mL | 07/31/2018 |
| K153569 | LIOFILCHEM S.R.L | Liofilchem MIC Test Strip (MTS) -Dalbavancin at 0.002 - 32 ug/ml | 06/22/2016 |
| K153687 | Liofilchem s.r.l | Liofilchem MIC Test Strip (MTS)-Vancomycin 0.016 -256 ug/mL | 03/31/2016 |
| K230479 | Liofilchem s.r.l. | ComASP Cefiderocol 0.008-128 | 05/18/2023 |
| K162854 | Liofilchem s.r.l. | Liofilchem MIC Test Strip (MTS) Meropenem 0.002-32.0 ug/ml | 12/19/2016 |
| K163517 | LIOFILCHEM S.R.L. | Liofilchem MIC Test Strip (MTS) Telavancin 0.016 - 256.0 ╡g/mL | 03/14/2017 |
| K161175 | LIOFILCHEM S.R.L. | Liofilchem MIC Test Strip (MTS)- Ceftolozane/Tazobactam 0.016/4 - 256/4 mcg/mL | 07/12/2016 |
| K170772 | Liofilchem s.r.l. | Liofilchem MIC Test Strip (MTS)- Clindamycin 0.016 - 256 ╡g/mL | 06/07/2017 |
| K191908 | Liofilchem s.r.l. | MTS Imipenem 0.016-256 ╡g/mL | 09/04/2019 |
| K183140 | Liofilchem s.r.l. | MTS Tetracycline 0.016 - 256 ug/mL | 01/11/2019 |
| K001887 | PASCO LABORATORIES, INC. | MODIFICATION TO PASCO MIC AND MIC/ID PANELS | 08/09/2000 |
| K992143 | PASCO LABORATORIES, INC. | MODIFICATION TO PASCO MIC AND MIC/ID PANELS (CLINDAMYCIN) | 09/16/1999 |
| K001516 | PASCO LABORATORIES, INC. | PASCO MIC AND MIC/ID PANELS | 07/12/2000 |
| K001612 | PASCO LABORATORIES, INC. | PASCO MIC AND MIC/ID PANELS | 07/18/2000 |
| K001953 | PASCO LABORATORIES, INC. | PASCO MIC AND MIC/ID PANELS | 08/10/2000 |
| K020331 | PASCO LABORATORIES, INC. | PASCO MIC AND MIC/ID PANELS | 03/20/2002 |
| K030933 | PASCO LABORATORIES, INC. | PASCO MIC AND MIC/ID PANELS | 05/01/2003 |
| K031205 | PASCO LABORATORIES, INC. | PASCO MIC AND MIC/ID PANELS | 06/13/2003 |
| K033119 | PASCO LABORATORIES, INC. | PASCO MIC AND MIC/ID PANELS | 11/18/2003 |
| K041214 | PASCO LABORATORIES, INC. | PASCO MIC AND MIC/ID PANELS | 06/07/2004 |
| K041776 | PASCO LABORATORIES, INC. | PASCO MIC AND MIC/ID PANELS | 08/03/2004 |
| K042331 | PASCO LABORATORIES, INC. | PASCO MIC AND MIC/ID PANELS | 10/07/2004 |
| K971951 | PASCO LABORATORIES, INC. | PASCO MIC AND MIC/ID PANELS | 08/15/1997 |
| K972567 | PASCO LABORATORIES, INC. | PASCO MIC AND MIC/ID PANELS | 08/20/1997 |
| K973695 | PASCO LABORATORIES, INC. | PASCO MIC AND MIC/ID PANELS | 11/05/1997 |
| K974362 | PASCO LABORATORIES, INC. | PASCO MIC AND MIC/ID PANELS | 02/12/1998 |
| K991925 | PASCO LABORATORIES, INC. | PASCO MIC AND MIC/ID PANELS | 08/26/1999 |
| K992059 | PASCO LABORATORIES, INC. | PASCO MIC AND MIC/ID PANELS | 08/30/1999 |
| K992108 | PASCO LABORATORIES, INC. | PASCO MIC AND MIC/ID PANELS (CEFEPIME) | 09/03/1999 |
| K031103 | PASCO LABORATORIES, INC. | PASCO MIC AND MIC/ID PANELS (ERTAPENEM) | 06/12/2003 |
| K031727 | PASCO LABORATORIES, INC. | PASCO MIC AND MIC/ID PANELS, GEMIFLOXACIN | 07/30/2003 |
| K992296 | PASCO LABORATORIES, INC. | PASCO MIC AND MIC/ID PANELS, VANCOMYCIN | 09/21/1999 |
| K962867 | SENSITITRE ALAMAR | SENSITITRE 18 HOUR SUSCEPTIBILITY PLATES | 09/30/1996 |
| K960220 | SENSITITRE LTD. | SENSITITRE 18 HOUR SUSCEPTIBILITY PLATES | 03/11/1996 |
| K081182 | SIEMENS | MICROSCAN DRIED GRAM-POSITIVE MIC/COMBO PANELS NEW ANTIMICROBIAL TEST - INDUCIBLE CLINDAMYCIN | 08/08/2008 |
| K060621 | TDS HOLDINGS INC. | SUSCEPTIBILITY TEST PLATE FOR ERTAPENEM 0.002-16UG/ML FOR GRAM NEGATIVE. SUSCEPTIBILITY TEST PLATE FOR ERTAPENEM 0.015- | 04/21/2006 |
| K150236 | THERMO FISHER SCIENTIFIC | Sensititre 18 - 24 hour MIC or Breakpoint Susceptibility System with Dalbavancin (0.0005 - 2ug/mL) | 07/27/2015 |
| K181946 | Thermo Fisher Scientific | Sensititre 18-24 hour MIC Breakpoint Susceptibility System with Plazomicin in the dilution range of 0.06-128 ug/mL | 08/08/2018 |
| K193538 | Thermo Fisher Scientific | Sensititre 18-24 hour MIC or Breakpoint Susceptibility System with Cefiderocol in the dilution range of 0.03-64 ╡g/ml | 03/12/2020 |
| K203741 | Thermo Fisher Scientific | Sensititre 18-24 hour MIC or Breakpoint Susceptibility System with Cefiderocol in the dilution range of 0.03-64 ug/ml | 12/20/2021 |
| K172454 | Thermo Fisher Scientific | Sensititre 18-24 hour MIC or Breakpoint Susceptibility System with Delafloxacin in the dilution range of 0.004-8 ug/mL | 10/13/2017 |
| K182797 | Thermo Fisher Scientific | Sensititre 18-24 hour MIC or Breakpoint Susceptibility System with Eravacycline in the dilution range of 0.008- 16 ╡g/mL | 11/30/2018 |
| K192250 | Thermo Fisher Scientific | Sensititre 18-24 hour MIC or Breakpoint Susceptibility System with Imipenem-Relebactam in the dilution range of 0.03/4-256/4 ug/mL | 10/16/2019 |
| K192729 | Thermo Fisher Scientific | Sensititre 18-24 Hour MIC or Breakpoint Susceptibility System with Lefamulin in the dilution range of 0.008-16ug/ml | 11/06/2019 |
| K173209 | Thermo Fisher Scientific | Sensititre 18-24 hour MIC or Breakpoint Susceptibility System with Meropenem/Vaborbactam in the Dilution Range of 0.008/8 - 18/8 ug/mL | 12/01/2017 |
| K183033 | Thermo Fisher Scientific | Sensititre 18-24 hour MIC or Breakpoint Susceptibility System with Omadacycline in the dilution range of 0.03-32ug/ml | 01/04/2019 |
| K231994 | Thermo Fisher Scientific | Sensititre 18-24 hour MIC or Breakpoint Susceptibility System with Sulbactam-durlobactam in the dilution range of 0.015/4-32/4 ug/mL | 08/25/2023 |
| K133773 | Thermo Fisher Scientific | SENSITITRE 18-24 HOUR MIC SUCEPTIBILITY SYSTEM | 02/27/2014 |
| K142151 | Thermo Fisher Scientific | SENSITITRE 18-24 HOUR SUSCEPTIBILITY PLATES | 12/23/2014 |
| K150556 | THERMO FISHER SCIENTIFIC | Sensititre 18-24 hours MIC or BP Susceptibility System with Ceftolozane/tazobactam (0.03/4- 64/4ug/mL) | 08/28/2015 |
| K202612 | Thermo Fisher Scientific | Sensititre 20-24 hour Haemophilus influenzae /Streptococcus pneumoniae MIC or Breakpoint Susceptibility System with Dtest (containing erythromycin at 1 ug/mL and clindamycin at 0.5 ug/mL) | 07/23/2021 |
| K183324 | Thermo Fisher Scientific | Sensititre 20-24 hour Haemophilus influenzae/Streptococcus pneumoniae MIC or Breakpoint Susceptibility System with Omadacycline in the dilution range of 0.008 - 32 ug/mL | 02/15/2019 |
| K193024 | Thermo Fisher Scientific | Sensititre 20-24 hour Haemophilus influenzae/Streptococcus pneumoniae MIC or Breakpoint, Susceptibility System with Lefamulin in the dilution range of 0.008-16ug/mL | 01/08/2020 |
| K230935 | Thermo Fisher Scientific | Sensititre 20-24 hour Haemophilus influenzae/Streptococcus pneumoniae MIC, or Breakpoint Susceptibility System with Imipenem-relebactam in the dilution, range of 0.03/4-128-4ug/ml (Haemophilus influenzae) | 06/30/2023 |
| K231988 | Thermo Fisher Scientific | Sensititre 20-24-hour Haemophilus influenzae/Streptococcus pneumoniae MIC or Breakpoint Susceptibility System with Dalbavancin in the dilution range of 0.0005-2╡g/ml | 08/30/2023 |
| K223844 | Thermo Fisher Scientific | Sensititre 20-24-hour Haemophilus influenzae/Streptococcus pneumoniae MIC or Breakpoint Susceptibility System with Delafloxacin in the dilution range of 0.00025-8ug/ml (Streptococcus species) and 0.000125-8ug/ml (Haemophilus influenzae) | 03/21/2023 |
| K133847 | Thermo Fisher Scientific | SENSITITRE HAEMOPHILUS / STREPTOCOCCUS PNEUMONIAE (HP) SUSCEPTIBILITY PLATES | 08/01/2014 |
| K140985 | Thermo Fisher Scientific | SENSITITRE HAEMOPHILUS/STREPTOCOCCUS PNEUMONIAE(HP) SUSCEPTIBILITY PLATES | 06/10/2014 |
| K142338 | THERMO FISHER SCIENTIFIC | Sensititre HP MIC Susceptibility Plate with Tedizolid (0.002-4 mcg/ml) | 03/02/2015 |
| K143381 | Thermo Fisher Scientific | Sensititre Susceptibility Plates | 02/19/2015 |
| K141000 | Thermo Fisher Scientific | SENSITITRE SUSCEPTIBILITY PLATES | 07/16/2014 |
| K141651 | Thermo Fisher Scientific | SENSITITRE SUSCEPTIBILITY PLATES | 10/21/2014 |
| K143288 | THERMO FISHER SCIENTIFIC | Sensititre Susceptibility plates | 04/01/2015 |
| K152774 | THERMO FISHER SCIENTIFIC | The Sensititre 18-24 hour MIC or Breakpoint Susceptibility System with Ceftazidime/Avibactam in the dilutions range of 0.015/4 - 32/4 ug/mL | 12/21/2015 |
| K171870 | Thermo Fisher Scientific | The Sensititre 18-24 hour MIC or Breakpoint Susceptibility System with Delafloxacin in the dilution range of 0.0005 û 8 ug/mL | 08/01/2017 |
| K172274 | Thermo Fisher Scientific | The Sensititre 20-24 hour Haemophilus influenzae/Streptococcus pneumoniae MIC or Breakpoint Susceptibility System with Delafloxacin in the dilution range of 0.00025-8╡g/mL | 08/30/2017 |
| K143526 | Thermo Fisher Scientific | The Sensititre HP MIC Susceptibility plate with Oritavancin (0.0005-8mcg/ml) | 03/05/2015 |
| K111615 | TREK DIAGNOSTIC SYSTEMS | SENSITITRE 18-24 HR SUSCEPTIBILITY PLATES | 11/08/2011 |
| K112276 | TREK DIAGNOSTIC SYSTEMS | VIZION | 11/16/2011 |
| K020859 | TREK DIAGNOSTIC SYSTEMS, INC. | CEFOTAXIME | 05/15/2002 |
| K020762 | TREK DIAGNOSTIC SYSTEMS, INC. | GATIFLOXIN | 05/09/2002 |
| K021339 | TREK DIAGNOSTIC SYSTEMS, INC. | HAEMOPHILUS/STREPTOCOCCUS PNEUMONIAE | 05/09/2002 |
| K012151 | TREK DIAGNOSTIC SYSTEMS, INC. | HAEMOPHILUS/STREPTOCOCCUS PNEUMONIAE (HP) MIC PLATE | 08/29/2001 |
| K062022 | TREK DIAGNOSTIC SYSTEMS, INC. | HAEMOPHILUS/STREPTOCOCCUS PNEUMONIAE (HP) MIC PLATE | 09/11/2006 |
| K012895 | TREK DIAGNOSTIC SYSTEMS, INC. | HEAMOPHILUS/STREPTOCOCCUS PNEUMONIAE | 10/30/2001 |
| K062839 | TREK DIAGNOSTIC SYSTEMS, INC. | MODIFICATION TO SENSITITRE HAEMOPHILUS/STREPTOCOCCUS PNEUMONIAE (HP) MIC PLATE | 11/09/2006 |
| K052091 | TREK DIAGNOSTIC SYSTEMS, INC. | SENSITIRE SUSCEPTIBILITY PLATES- ADDITIONAL ANTIMICROBICS | 09/21/2005 |
| K073653 | TREK DIAGNOSTIC SYSTEMS, INC. | SENSITITRE 18 - 24 HOUR SUSCEPTIBILITY PLATE | 03/20/2008 |
| K011803 | TREK DIAGNOSTIC SYSTEMS, INC. | SENSITITRE 18 - 24 HOURS SUSCEPTIBILITY PLATES | 08/15/2001 |
| K031545 | TREK DIAGNOSTIC SYSTEMS, INC. | SENSITITRE 18-24 HOUR SUSCEPTIBILITY PLATE | 07/16/2003 |
| K073424 | TREK DIAGNOSTIC SYSTEMS, INC. | SENSITITRE 18-24 HOUR SUSCEPTIBILITY PLATES | 01/22/2008 |
| K083606 | TREK DIAGNOSTIC SYSTEMS, INC. | SENSITITRE 18-24 HOUR SUSECEPTIBILITY PLATES | 03/24/2009 |
| K001573 | TREK DIAGNOSTIC SYSTEMS, INC. | SENSITITRE 18-24 HOURS SUSCEPTIBILITY PLATES | 07/18/2000 |
| K022656 | TREK DIAGNOSTIC SYSTEMS, INC. | SENSITITRE 18-24 HOURS SUSCEPTIBILITY PLATES | 10/08/2002 |
| K022775 | TREK DIAGNOSTIC SYSTEMS, INC. | SENSITITRE 18-24 HOURS SUSCEPTIBILITY PLATES | 09/25/2002 |
| K033522 | TREK DIAGNOSTIC SYSTEMS, INC. | SENSITITRE 18-24 HOURS SUSCEPTIBILITY PLATES | 02/03/2004 |
| K001035 | TREK DIAGNOSTIC SYSTEMS, INC. | SENSITITRE 18-24 HOURS SUSCEPTIBILITY PLATES (GATIFLOXACIN) | 05/23/2000 |
| K001036 | TREK DIAGNOSTIC SYSTEMS, INC. | SENSITITRE 18-24 HOURS SUSCEPTIBILITY PLATES (MOXIFLOXACIN) | 06/06/2000 |
| K001558 | TREK DIAGNOSTIC SYSTEMS, INC. | SENSITITRE 18-24 HOURS SUSCEPTIBILITY PLATES (QUINUPRISTIN/DALFOPRISTIN) | 07/24/2000 |
| K073558 | TREK DIAGNOSTIC SYSTEMS, INC. | SENSITITRE 18-24 SUSCEPTIBILITY PLATE | 03/13/2008 |
| K093865 | TREK DIAGNOSTIC SYSTEMS, INC. | SENSITITRE 18-24HR SUSCEPTIBILITY PLATES | 02/17/2010 |
| K062190 | TREK DIAGNOSTIC SYSTEMS, INC. | SENSITITRE HAEMOPHILUS / STREPTOCOCCUS PNEUMONIAE (HP) MIC PLATES | 08/31/2006 |
| K062841 | TREK DIAGNOSTIC SYSTEMS, INC. | SENSITITRE HAEMOPHILUS/STREPTOCOCCUS PNEUMONIAE (HP) MIC AND SUSCEPTIBILITY PLATES | 12/20/2006 |
| K013075 | TREK DIAGNOSTIC SYSTEMS, INC. | SENSITITRE HAEMOPHILUS/STREPTOCOCCUS PNEUMONIAE (HP) MIC PLATE | 11/26/2001 |
| K014258 | TREK DIAGNOSTIC SYSTEMS, INC. | SENSITITRE HAEMOPHILUS/STREPTOCOCCUS PNEUMONIAE (HP) MIC PLATE | 02/19/2002 |
| K012565 | TREK DIAGNOSTIC SYSTEMS, INC. | SENSITITRE HAEMOPHILUS/STREPTOCOCCUS PNEUMONIAE (HP) MIC PLATE | 09/12/2001 |
| K012921 | TREK DIAGNOSTIC SYSTEMS, INC. | SENSITITRE HAEMOPHILUS/STREPTOCOCCUS PNEUMONIAE (HP) MIC PLATE | 11/02/2001 |
| K021627 | TREK DIAGNOSTIC SYSTEMS, INC. | SENSITITRE HAEMOPHILUS/STREPTOCOCCUS PNEUMONIAE (HP) MIC PLATE | 06/20/2002 |
| K021997 | TREK DIAGNOSTIC SYSTEMS, INC. | SENSITITRE HAEMOPHILUS/STREPTOCOCCUS PNEUMONIAE (HP) MIC PLATE | 09/25/2002 |
| K062722 | TREK DIAGNOSTIC SYSTEMS, INC. | SENSITITRE HAEMOPHILUS/STREPTOCOCCUS PNEUMONIAE (HP) MIC PLATE | 10/20/2006 |
| K062783 | TREK DIAGNOSTIC SYSTEMS, INC. | SENSITITRE HAEMOPHILUS/STREPTOCOCCUS PNEUMONIAE (HP) MIC PLATE | 10/26/2006 |
| K062816 | TREK DIAGNOSTIC SYSTEMS, INC. | SENSITITRE HAEMOPHILUS/STREPTOCOCCUS PNEUMONIAE (HP) MIC PLATE | 11/01/2006 |
| K032382 | TREK DIAGNOSTIC SYSTEMS, INC. | SENSITITRE HAEMOPHILUS/STREPTOCOCCUS PNEUMONIAE (HP) MIC PLATES | 08/29/2003 |
| K040619 | TREK DIAGNOSTIC SYSTEMS, INC. | SENSITITRE HAEMOPHILUS/STREPTOCOCCUS PNEUMONIAE (HP) MIC PLATES | 04/07/2004 |
| K040846 | TREK DIAGNOSTIC SYSTEMS, INC. | SENSITITRE HAEMOPHILUS/STREPTOCOCCUS PNEUMONIAE (HP) MIC PLATES | 04/26/2004 |
| K013580 | TREK DIAGNOSTIC SYSTEMS, INC. | SENSITITRE HAEMOPHILUS/STREPTOCOCCUS PNEUMONIAE (HP) MIC SUSCEPTIBILITY PLATE | 12/12/2001 |
| K013925 | TREK DIAGNOSTIC SYSTEMS, INC. | SENSITITRE HAEMOPHILUS/STREPTOCOCCUS PNEUMONIAE (HP) MIC SUSCEPTIBILITY PLATES | 12/21/2001 |
| K014259 | TREK DIAGNOSTIC SYSTEMS, INC. | SENSITITRE HEAMOPHILUS/STREPTOCOCCUS PNEUMONIAE (HP) MIC PLATE | 03/26/2002 |
| K003834 | TREK DIAGNOSTIC SYSTEMS, INC. | SENSITITRE SUSCEPTIBILITY PLATES-ADDITIONAL ANTIMICROBICS | 02/23/2001 |
| K003868 | TREK DIAGNOSTIC SYSTEMS, INC. | SENSITITRE SUSCEPTIBILITY PLATES-ADDITIONAL ANTIMICROBICS | 02/27/2001 |
| K081520 | TREK DIAGNOSTIC SYSTEMS, INC. | SENSITITRE VIZION | 10/24/2008 |
| K004045 | TREK DIAGNOSTIC SYSTEMS, INC. | SUSCEPTIBILITY TEST PANEL | 03/06/2001 |
| K060783 | TREK DIAGNOSTIC SYSTEMS, INC. | SUSCEPTIBILITY TEST PLATE FOR VANCOMYCIN VRSA LIMITATION REMOVAL | 05/16/2006 |
| K111429 | TREK DIAGNOSTIC SYSTEMS, LTD. | SENSITITRE (R) HP MIC SUSCEPTIBILITY PLATE WITH CEFAROLINE (0.004-8UG/ML) AND THE SENSITITRE (R) 18-24 HOUR MIC SUSCE... | 08/18/2011 |
| K092445 | TREK DIAGNOSTIC SYSTEMS, LTD. | SENSITITRE 18-24 HOUR SUSCEPTIBILITY PLATES | 12/16/2009 |
| K062681 | TREK DIAGNOSTIC SYSTEMS, LTD. | SENSITITRE HAEMOPHILUS/STREPTOCOCCUS PNEUMONIAE (HP) MIC PLATE | 10/13/2006 |
| K041534 | TREK DIAGNOSTIC SYSTEMS, LTD. | SENSITITRE HAEMOPHILUS/STREPTOCOCCUS PNEUMONIAE (HP) MIC SUSCEPTIBILITY PLATE AND SUSCEPTIBILITY TEST PANEL | 07/27/2004 |
| K093741 | TREK DIAGNOSTIC SYSTEMS, LTD. | SENSITIVE HAEMOPHILUS INFLUENZAE, STREPTOCOCCUS PNEUMONIA, (HP) MIC SUSCEPTIBILITY PLATES | 02/25/2010 |
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