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
K954319 AB BIODISK AMOXICILLIN/CLAVULANIC ACID 2/1 12/12/1995
K042392 AB BIODISK DAPTOMYCIN 12/13/2004
K946364 AB BIODISK E TEST FOR OFLOXACIN 05/02/1995
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
K945433 AB BIODISK ETEST/CEFTRIAXONE/HAEMOPHILUS/PNEUMOCOCCUS 03/17/1995
K953223 AB BIODISK PIPERACILIN TAZOBACTAM 4 UG 08/15/1995
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
K913459 AB BIODISK THE E TEST, MODIFICATION 09/25/1991
K951879 AB BIODISK TICARCILLIN/CLAVULANIC ACID 2 07/07/1995
K983027 AB BIODISK TRIMETHOPRIM/SULPHAMETHOXAZOLE 10/02/1998
K990685 AB BIODISK TRIMETHOPRIM/SULPHAMETHOXAZOLE (1/19) 03/26/1999
K950328 AB BIODISK NORTH AMERICA, INC. AMOXICILLIN/CLAVULANIC ACID 2/1 04/14/1995
K935519 AB BIODISK NORTH AMERICA, INC. ETEST FOR AMPICILLIN/SULBACTAM 2/1 11/04/1994
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
K910345 ALAMAR ANTIMICROBIAL CEFOPERAZONE 02/25/1991
K910346 ALAMAR ANTIMICROBIAL CEFTRIAXONE 02/25/1991
K911391 ALAMAR ANTIMICROBIAL SUSCEPT. TEST PANEL (CEFTIZOXIME) 05/08/1991
K911390 ALAMAR ANTIMICROBIAL SUSCEPT. TEST PANEL(TRIMETHOPRIM) 05/08/1991
K910484 ALAMAR ANTIMICROBIAL SUSCEPTIBILITY TEST PANEL 03/11/1991
K911392 ALAMAR ANTIMICROBIAL SUSCEPTIBILITY TEST PANEL (CEFOTETAN 05/08/1991
K911389 ALAMAR ANTIMICROBIAL SUSCEPTIBILITY TEST PANEL (IMIPENEM) 05/08/1991
K911555 ALAMAR BIOSCIENCES LABORATORY, INC. ANITIMICROBIAL SUSCEPT. TEST PANEL AMOX./CLAVUL. 04/22/1991
K911303 ALAMAR BIOSCIENCES LABORATORY, INC. ANTIMICROBIAL AMIKACIN 04/18/1991
K911185 ALAMAR BIOSCIENCES LABORATORY, INC. ANTIMICROBIAL AMPICILLIN 04/22/1991
K911186 ALAMAR BIOSCIENCES LABORATORY, INC. ANTIMICROBIAL AMPICILLIN/SULBACTAM 04/17/1991
K911187 ALAMAR BIOSCIENCES LABORATORY, INC. ANTIMICROBIAL CEFUROXIME 04/17/1991
K911305 ALAMAR BIOSCIENCES LABORATORY, INC. ANTIMICROBIAL GENTAMICIN 04/22/1991
K904689 ALAMAR BIOSCIENCES LABORATORY, INC. ANTIMICROBIAL SUSCEPT TEST PANEL/ADD ANTIBIOTICS 02/07/1991
K911559 ALAMAR BIOSCIENCES LABORATORY, INC. ANTIMICROBIAL SUSCEPT. TEST PANEL CEFONICID 04/22/1991
K911558 ALAMAR BIOSCIENCES LABORATORY, INC. ANTIMICROBIAL SUSCEPT. TEST PANEL NITROFURANTOIN 05/15/1991
K911556 ALAMAR BIOSCIENCES LABORATORY, INC. ANTIMICROBIAL SUSCEPT. TEST PANEL TICARC./CLAVUL. 04/22/1991
K911557 ALAMAR BIOSCIENCES LABORATORY, INC. ANTIMICROBIAL SUSCEPT. TEST PANEL TICARCILLIN 04/22/1991
K924500 ALAMAR BIOSCIENCES LABORATORY, INC. ANTIMICROBIAL SUSCEPTIBILITY TEST 11/30/1992
K905853 ALAMAR BIOSCIENCES LABORATORY, INC. ANTIMICROBIAL SUSCEPTIBILITY TEST PANEL 02/07/1991
K896965 ALAMAR BIOSCIENCES LABORATORY, INC. ANTIMICROBIAL SUSCEPTIBILITY TEST PANEL 01/29/1990
K930055 ALAMAR BIOSCIENCES LABORATORY, INC. ANTIMICROBIAL SUSCEPTIBILITY TEST PANEL 04/05/1993
K930469 ALAMAR BIOSCIENCES LABORATORY, INC. ANTIMICROBIAL SUSCEPTIBILITY TEST PANEL 06/25/1993
K922168 ALAMAR BIOSCIENCES LABORATORY, INC. ANTIMICROBIAL SUSCEPTIBILITY TEST PANEL 07/28/1992
K922780 ALAMAR BIOSCIENCES LABORATORY, INC. ANTIMICROBIAL SUSCEPTIBILITY TEST PANEL 08/20/1992
K894514 ALAMAR BIOSCIENCES LABORATORY, INC. ANTIMICROBIAL SUSCEPTIBILITY TEST PANEL 11/06/1989
K904523 ALAMAR BIOSCIENCES LABORATORY, INC. ANTIMICROBIAL SUSCEPTIBILITY TEST PANEL/MODIFIED 12/21/1990
K922003 ALAMAR BIOSCIENCES LABORATORY, INC. ANTIMICROBIAL SUSCETIBILITY TEST PANEL 08/19/1992
K911304 ALAMAR BIOSCIENCES LABORATORY, INC. ANTIMICROBIAL TOBRAMYCIN 04/22/1991
K933885 ALAMAR BIOSCIENCES, INC. ALAMAR BIOSCIENCES LABORATORY, INC. ANTIMICROBIAL SUSCEPTIBILITY TEST PANEL 11/16/1993
K944723 ALAMAR BIOSCIENCES, INC. ANTIMICROBIAL SUSCEPTIBILITY TEST PANEL MODIFICATION 10/21/1994
K943756 ALAMAR BIOSCIENCES, INC. MICRODILUTION DEVICE FOR DETERMINING GENTAMICIN & STRRPTOMYCIN FOR DETECTION OF HIGH LEVEL AMINOGLYCOSIDE RESISTANCE 02/17/1995
K861584 AMERICAN MICRO SCAN GRAM NEGATIVE COMBO PANEL TYPE 3 06/17/1986
K863776 AMERICAN MICRO SCAN MICRODILUTION MIC PANELS 02/02/1987
K862140 AMERICAN MICRO SCAN MICRODILUTION PANELS 07/16/1986
K912965 ANALYTAB PRODUCTS, INC. API UNISCEPT KB 09/06/1991
K912964 ANALYTAB PRODUCTS, INC. API UNISCEPT MIC/UNISCEPT MICRO-MIC 08/29/1991
K861408 ANALYTAB PRODUCTS, INC. MODIFIED UNISCEPT KB LABELING AMENDMENT 05/16/1986
K860369 ANALYTICAL PRODUCTS, INC. API UNISCEPT MICRO-MIC CEFTRIAXONE/UNISCEPT MIC 03/11/1986
K864891 ANALYTICAL PRODUCTS, INC. API UNISCEPT (TM) KB 02/20/1987
K895796 ANALYTICAL PRODUCTS, INC. API UNISCEPT KB 11/13/1989
K922926 ANALYTICAL PRODUCTS, INC. API UNISCEPT KB/TYPE 2 AND 3 10/13/1992
K923684 ANALYTICAL PRODUCTS, INC. API UNISCEPT MIC/TYPE 2 AND 3 AND MICRO MIC 12/03/1992
K874466 ANALYTICAL PRODUCTS, INC. API UNISCEPT(R) MICRO-MIC(R) SYSTEM/UNISCEPT MIC 12/09/1987
K870663 ANALYTICAL PRODUCTS, INC. API UNISCEPT(R) MICRO-MIC(R) SYSTEM/UNISCEPT(R)MIC 03/23/1987
K884509 ANALYTICAL PRODUCTS, INC. MODIFICATION MIC/API UNISCEPT(R) 11/22/1988
K884510 ANALYTICAL PRODUCTS, INC. MODIFICATION MICRO-MIC 11/22/1988
K880598 ANALYTICAL PRODUCTS, INC. MODIFICATIONS TO API UNISCEPT (R) KB 03/23/1988
K864069 AUSTIN BIOLOGICAL LABORATORIES PRECEPT (TM) TICARCILLIN/CLAVULANIC ACID 11/13/1986
K854577 AUSTIN BIOLOGICAL LABORATORIES PRECEPT AMOXICILLIN/CLAVVLANIC ACID (AUGMENTIN) 02/05/1986
K862446 AUSTIN BIOLOGICAL LABORATORIES PRECEPT CEFTAZIDIME 07/11/1986
K862560 AUSTIN BIOLOGICAL LABORATORIES PRECEPT CEFTIZOXIME 07/11/1986
K850833 AUSTIN BIOLOGICAL LABORATORIES PRECEPT TM MEZLOCILLIN 09/13/1985
K860195 AUSTIN BIOLOGICAL LABORATORIES PRECEPT TRIMETHOPRIM/SULFAMETHOXAZOLE 02/20/1986
K874727 AUSTIN BIOLOGICAL LABORATORIES PRECEPT(TM) CIPROFLOXACIN 02/18/1988
K941317 BAXTER DIAGNOSTICS, INC. DRIED GRAM NEGATIVE/CEFMETAZOLE 01/31/1995
K950817 BAXTER DIAGNOSTICS, INC. DRIED GRAM POSITIVE MIC/COMBO PANELS/PNEUMOCOCCI 04/25/1995
K926545 BAXTER DIAGNOSTICS, INC. DRIED GRAM-NEGATIVE MIC/COMBO PANELS 03/26/1993
K932082 BAXTER DIAGNOSTICS, INC. DRIED GRAM-NEGATIVE MIC/COMBO PANELS 07/20/1993
K944651 BAXTER DIAGNOSTICS, INC. DRIED GRAM-POSITIVE MIC/COMBO PANELS 11/18/1994
K934458 BAXTER DIAGNOSTICS, INC. DRIED GRAM-POSITIVE MIC/COMBO PANELS 07/18/1995
K943510 BAXTER DIAGNOSTICS, INC. DRIED GRAM-POSITIVE MIC/COMBO PANELS 12/02/1994
K934323 BAXTER DIAGNOSTICS, INC. DRIED GRAM-POSITIVE MIC/COMBO PANELS, AMP/EXT DIL 10/19/1994
K942267 BAXTER DIAGNOSTICS, INC. DRIED GRAM-POSITIVE MIC/COMBO PANELS/CEFMETAZOLE 01/09/1995
K941459 BAXTER DIAGNOSTICS, INC. GRAM POSITIVE DRIED OVERNIGHT PANELS/LOMEFLOX 02/03/1995
K940917 BAXTER DIAGNOSTICS, INC. LORACARBEF GRAM-NAGATIVE PANELS 02/08/1995
K942089 BAXTER DIAGNOSTICS, INC. MICRODILUTION/LORACARBEF PANELS 01/09/1995
K922458 BAXTER HEALTHCARE CORP. DRIED GRAM-NEGATIVE AND POSITIVE MIC/COMBO PANELS 12/11/1992
K874876 BAXTER HEALTHCARE CORP. GRAM - & GRAM + MIC/COMBO & BREAKPOINT/COMBO PANEL 01/11/1988
K883076 BAXTER HEALTHCARE CORP. GRAM NEGATIVE & GRAM POSITIVE MIC/COMBO PANELS 09/07/1988
K883394 BAXTER HEALTHCARE CORP. GRAM NEGATIVE AND GRAM POSITIVE MIC/COMBO PANELS 09/07/1988
K893977 BAXTER HEALTHCARE CORP. GRAM NEGATIVE AND POSITIVE MIC/COMBO PANELS 08/15/1989
K894146 BAXTER HEALTHCARE CORP. GRAM NEGATIVE AND POSITIVE MIC/COMBO PANELS 09/05/1989
K880430 BAXTER HEALTHCARE CORP. GRAM NEGATIVE MIC/COMBO PANELS 04/12/1988
K874426 BD BECTON DICKINSON VACUTAINER SYSTEMS PREANALYTIC NEW ANTIMICRO. AGENTS:AUGMENTIN,AZTREONAM,CIPROFLO 12/02/1987
K896278 BD BECTON DICKINSON VACUTAINER SYSTEMS PREANALYTIC SCEPTOR - NEW ANTIMICROBIAL AGENT - CEFOTETAN 03/07/1990
K881716 BD BECTON DICKINSON VACUTAINER SYSTEMS PREANALYTIC SCEPTOR - NEW ANTIMICROBIAL AGENT: CEFACLOR 07/14/1988
K882909 BD BECTON DICKINSON VACUTAINER SYSTEMS PREANALYTIC SCEPTOR - NEW ANTIMICROBIAL AGENT: RIFAMPIN 08/29/1988
K854102 BD BECTON DICKINSON VACUTAINER SYSTEMS PREANALYTIC SCEPTOR ENTERIC MIC PANEL 11/14/1985
K882300 BD BECTON DICKINSON VACUTAINER SYSTEMS PREANALYTIC SCEPTOR ENTERIC MIC PANEL (REVISED 4/88) 07/12/1988
K854103 BD BECTON DICKINSON VACUTAINER SYSTEMS PREANALYTIC SCEPTOR ENTERIC MIC/ID PANEL 11/14/1985
K882301 BD BECTON DICKINSON VACUTAINER SYSTEMS PREANALYTIC SCEPTOR ENTERIC MIC/ID PANEL (REVISED 4/88) 07/12/1988
K882911 BD BECTON DICKINSON VACUTAINER SYSTEMS PREANALYTIC SCEPTOR EXTEN. OF CONCENTRATION RANGE: PENCILLIN 08/17/1988
K861187 BD BECTON DICKINSON VACUTAINER SYSTEMS PREANALYTIC SCEPTOR GRAM NEGATIVE BREAKPOINT /ID PANEL 06/16/1986
K854099 BD BECTON DICKINSON VACUTAINER SYSTEMS PREANALYTIC SCEPTOR GRAM NEGATIVE URINE ISOLATE MIC/ID PANEL 11/14/1985
K861186 BD BECTON DICKINSON VACUTAINER SYSTEMS PREANALYTIC SCEPTOR GRAM POSITIVE BREAKPOINT/ID PANEL 06/13/1986
K854101 BD BECTON DICKINSON VACUTAINER SYSTEMS PREANALYTIC SCEPTOR GRAM POSITIVE MIC PANEL 11/14/1985
K854100 BD BECTON DICKINSON VACUTAINER SYSTEMS PREANALYTIC SCEPTOR GRAM POSITIVE MIC/ID PANEL 11/14/1985
K883800 BD BECTON DICKINSON VACUTAINER SYSTEMS PREANALYTIC SCEPTOR GRAM-NEGATIVE BREAKPOINT/ID PANEL 10/12/1988
K882299 BD BECTON DICKINSON VACUTAINER SYSTEMS PREANALYTIC SCEPTOR GRAM-NEGATIVE URINE ISOLATE MIC/ID PANEL 07/18/1988
K883798 BD BECTON DICKINSON VACUTAINER SYSTEMS PREANALYTIC SCEPTOR GRAM-POSITIVE BREAKPOINT/ID PANEL 10/12/1988
K882910 BD BECTON DICKINSON VACUTAINER SYSTEMS PREANALYTIC SCEPTOR NEW ANTIMICROBIAL AGENT: AMPICILLIN/SULBAC 08/17/1988
K882912 BD BECTON DICKINSON VACUTAINER SYSTEMS PREANALYTIC SCEPTOR NEW ANTIMICROBIAL AGENT: IMIPENEM 08/17/1988
K854098 BD BECTON DICKINSON VACUTAINER SYSTEMS PREANALYTIC SCEPTOR PSEUDOMONAS PLUS MIC PANEL 11/14/1985
K883552 BD BECTON DICKINSON VACUTAINER SYSTEMS PREANALYTIC SCEPTOR PSEUDOMONAS PLUS MIC PANEL CAT.# 80328 09/26/1988
K854097 BD BECTON DICKINSON VACUTAINER SYSTEMS PREANALYTIC SCEPTOR PSEUDOMONAS PLUS MIC/ID PANEL 11/14/1985
K883554 BD BECTON DICKINSON VACUTAINER SYSTEMS PREANALYTIC SCEPTOR PSEUDOMONAS PLUS MIC/ID PANEL #80329 09/26/1988
K883553 BD BECTON DICKINSON VACUTAINER SYSTEMS PREANALYTIC SCEPTOR RESISTANT GRAM-NEGATIVE MIC PANEL #80331 09/26/1988
K883555 BD BECTON DICKINSON VACUTAINER SYSTEMS PREANALYTIC SCEPTOR RESISTANT GRAM-NEGATIVE MIC/ID #80332 09/26/1988
K883550 BD BECTON DICKINSON VACUTAINER SYSTEMS PREANALYTIC SCEPTOR STAPHYLOCOCCUS MIC #80324 09/26/1988
K883551 BD BECTON DICKINSON VACUTAINER SYSTEMS PREANALYTIC SCEPTOR STAPHYLOCOCCUS MIC/ID PANEL #80325 09/27/1988
K883549 BD BECTON DICKINSON VACUTAINER SYSTEMS PREANALYTIC SCEPTOR STREPTOCOCCUS MIC PANEL #80322 09/26/1988
K883548 BD BECTON DICKINSON VACUTAINER SYSTEMS PREANALYTIC SCEPTOR STREPTOCOCCUS MIC/ID PANEL #80323 09/26/1988
K881846 BD BECTON DICKINSON VACUTAINER SYSTEMS PREANALYTIC SCEPTOR- NEW ANTIMICROBIAL AGENT: NORFLOXACIN 07/08/1988
K894189 BD BECTON DICKINSON VACUTAINER SYSTEMS PREANALYTIC SCEPTOR-NEW ANTIMICROBIAL AGENT:TICAR/CLAVU ACID 10/10/1989
K870719 BD BECTON DICKINSON VACUTAINER SYSTEMS PREANALYTIC SENSIR SYSTEM 06/15/1987
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
K152346 BECKMAN COULTER, INC. MicroScan Dried Gram Positive MIC/Combo Panels - Vancomycin (0.25-64 ug/mL) 09/16/2015
K854525 BECKMAN INSTRUMENTS, INC. FOX FASTIDIOUS TEST PANEL 04/11/1986
K853805 BECKMAN INSTRUMENTS, INC. MICRO-MEDIA MICRODILUTION TEST PANELS 03/19/1986
K926294 BECTON DICKINSON MICROBIOLOGY SYSTEMS BBL CRYSTAL MRSA ID SYSTEM 05/18/1993
K941997 BECTON DICKINSON MICROBIOLOGY SYSTEMS BBL CRYSTAL MRSA ID SYSTEM 01/27/1995
K951539 BECTON DICKINSON MICROBIOLOGY SYSTEMS ENTEROCOCCUS SCREENING MEDIUM 06/13/1995
K950123 BECTON DICKINSON MICROBIOLOGY SYSTEMS SCEPTOR SYSTEM PANELS 03/23/1995
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
K183031 bioMerieux SA ETEST Meropenem/Vaborbactam (MEV) (0.004/8-64/8 ?g/mL) 01/11/2019
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
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
K061687 DADE BEHRING, INC. MICROSCAN DRIED GRAM NEGATIVE MIC/COMBO PANELS 07/21/2006
K061536 DADE BEHRING, INC. MICROSCAN DRIED GRAM NEGATIVE MIC/COMBO PANELS 07/18/2006
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
K983922 DADE MICROSCAN, INC. DRIED GRAM-NEGATIVE AND GRAM-POSITIVE MIC/COMBO PANELS 06/17/1999
K983711 DADE MICROSCAN, INC. DRIED GRAM-NEGATIVE AND GRAM-POSITIVE MIC/COMBO PANELS 04/27/1999
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
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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
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K133847 Thermo Fisher Scientific SENSITITRE HAEMOPHILUS / STREPTOCOCCUS PNEUMONIAE (HP) SUSCEPTIBILITY PLATES 08/01/2014
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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
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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
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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
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K093741 TREK DIAGNOSTIC SYSTEMS, LTD. SENSITIVE HAEMOPHILUS INFLUENZAE, STREPTOCOCCUS PNEUMONIA, (HP) MIC SUSCEPTIBILITY PLATES 02/25/2010


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