FDA 510(k) Applications Submitted by bioMerieux, Inc.

FDA 510(k) Number Submission Date Device Name Applicant
K993319 10/04/1999 VIDAS TOXO IGG II (TXG) ASSAY MODEL 30 210 BIOMERIEUX, INC.
K141149 05/05/2014 VITEK 2 AST GP CEFTAROLINE BIOMERIEUX, INC.
K133952 12/23/2013 VITEK 2 AST YS FLUCYTOSINE, VITEK 2 AST YEAST FLUCYTOSINE BIOMERIEUX, INC.
K151923 07/13/2015 VITEK 2 AST-Yeast Micafungin (0.06-8 mcg/mL) BIOMERIEUX, INC.
K170670 03/06/2017 Etest Ceftolozane/ Tazobactam (0.016-256 ug/ml) bioMerieux, Inc.
K190616 03/11/2019 VITEK 2 AST-Gram Positive Dalbavancin (<= 0.015 - >= 1 ╡g/mL) bioMerieux, Inc.
K172944 09/26/2017 VITEK 2 AST-GN Ceftazidime/Avibactam <=0.12 û >=16 ╡g/mL bioMerieux, Inc.
K193299 11/27/2019 VITEK 2 AST-Gram Negative Ceftazidime (=<0.5 - =>32 ╡g/mL) BioMerieux, Inc.
K183415 12/10/2018 VITEK 2 AST-Gram Negative Imipenem (= 16 ug/mL) bioMerieux, Inc.
K183551 12/20/2018 VITEK 2 AST-Gram Negative Minocycline (<= 0.5 - >= 32 ug/mL) bioMerieux, Inc.
K201675 06/19/2020 VITEK 2 AST-Gram Negative Meropenem (<= 0.25 - >=16 ╡g/mL) bioMerieux, Inc.
K202396 08/21/2020 VITEK 2 AST-Gram Positive Fosfomycin (<=8 - >=256 ug/mL) bioMerieux, Inc.
K213931 12/16/2021 VITEK 2 AST-Gram Negative Omadacycline (<=0.25 - >=16 ╡g/mL) bioMerieux, Inc.
K121446 05/15/2012 BACT/ALERT PF PLUS CULTURE BOTTLE BIOMERIEUX, INC.
K121863 06/26/2012 VITEK 2 AST-ST CEFOTAXIME BIOMERIEUX, INC.
K122547 08/21/2012 GRAM POSTITVE CLINDAMYCIN BIOMERIEUX, INC.
K113783 12/22/2011 VITEK 2 AST- GRAM POSTIVE PENICILLIN FOR STREPTOCOCCUS PNEUMONIAE BIOMERIEUX, INC.
K190405 02/19/2019 BACT/ALERT MP Reagent System bioMerieux, Inc.
K191766 07/01/2019 VITEK 2 AST-Gram Negative Eravacycline (<=0.12 - >=4╡g/mL) bioMerieux, Inc.
K222378 08/05/2022 VITEK 2 AST-Gram Negative Levofloxacin (/=8 ug/mL) bioMerieux, Inc.
K172731 09/11/2017 VITEK 2 AST-GN Amikacin (<=1 ->=64 ug/mL) bioMerieux, Inc.
K213241 09/30/2021 VITEK 2 AST-Yeast Fluconazole (<=0.5->=64 ╡g/mL), VITEK 2 AST-YS Fluconazole (<=0.5->=64 ╡g/mL), VITEK 2 AST-YS Fluconazole BioMerieux, Inc.
K213899 12/14/2021 VITEK 2 AST-Yeast Caspofungin (<=0.125 - >=8 ╡g/mL), VITEK 2 AST-YS Caspofungin (<=0.125 - >=8 ╡g/mL), VITEK 2 AST-YS Caspofungin bioMerieux, Inc.
K183524 12/19/2018 VITEK2 AST-Gram Negative Delafloxacin (<=0.06->=4 ug/mL) bioMerieux, Inc.
K193567 12/23/2019 VITEK 2 AST- Gram Negative Polymyxin B (<=0.25 û >=16 ug/mL) BioMerieux, Inc.
K001460 05/10/2000 VIDAS H. PYLORI IGG (HPY) ASSAY, MODEL 30 192 BIOMERIEUX, INC.
K121002 04/02/2012 ETEST CEFTAROLINE BIOMERIEUX, INC.
K121546 05/25/2012 VITEK 2 GRAM NEGATIVE DOXYCYCLINE BIOMERIEUX, INC.
K111976 07/12/2011 VITEK 2 STREPTOCOCCUS ERYTHROMYCIN BIOMERIEUX, INC.
K112228 08/03/2011 VITEK 2 STREPTOCOCCUS LEVOFLOXACIN BIOMERIEUX, INC.
K181412 05/30/2018 VITEK MS bioMerieux, Inc.
K163006 10/28/2016 VITEK 2 AST-GN Tigecycline (<0.5->8 ug/mL) bioMerieux, Inc.
K151688 06/23/2015 chromID MRSA bioMerieux, Inc.
K050513 03/01/2005 MDA B.30 BIOMERIEUX, INC.
K121100 04/11/2012 VITEK 2 AST STREPTOCOCUS VANCOMYCIN BIOMERIEUX, INC.
K121461 05/17/2012 BACT/ALERT FA PLUS CULTURE BOTTLE BIOMERIEUX, INC.
K031737 06/04/2003 BACT/ALERT MP CULTURE BOTTLES (PLASTIC) BIOMERIEUX, INC.
K102740 09/22/2010 NUCLISENS EASYQ MRSA; NUCLISENS EASYQ ANALYZER; NUCLISENS EASYQ INCUBATOR (110 VOLT); NUCLISENS DIRECTOR V.2.6 BIOMERIEUX, INC.
K133817 12/16/2013 VITEK 2 AST - YEAST FLUCONAZOLE BIOMERIEUX, INC.
K051030 04/22/2005 COAG-A-MATE MTX III BIOMERIEUX, INC.
K063492 11/17/2006 VITEK 2 GRAM POSITIVE ERYTHROMYCIN FOR STREPTOCOCCUS PNEUMONIAE BIOMERIEUX, INC.
K072038 07/25/2007 VITEK 2 GRAM NEGATIVE LEVOFLOXACIN BIOMERIEUX, INC.
K050075 01/12/2005 VITEK 2 GRAM POSITIVE DAPTOMYCIN BIOMERIEUX, INC.
K050076 01/12/2005 VITEK 2 GRAM POSITIVE ERTAPENEM BIOMERIEUX, INC.
K110106 01/13/2011 VITEK 2 GRAM NEGATIVE TRIMETHOPRIM/SULFAMETHOAZOLE BIOMERIEUX, INC.
K080201 01/28/2008 VITEK 2 GRAM POSITIVE INDUCIBLE CLINDAMYCIN RESISTANCE BIOMERIEUX, INC.
K050816 03/31/2005 VITEK 2 GRAM POSITIVE MEROPENEM BIOMERIEUX, INC.
K091126 04/20/2009 VITEK 2 GRAM POSITIVE DAPTOMYCIN BIOMERIEUX, INC.
K181368 05/23/2018 VITEK 2 AST-YS Micafungin (<=0.06 - =>8 ╡g/mL) bioMerieux, Inc.
K161816 07/01/2016 BacT/ALERT VIRTUO Microbial Detection System, BacT/ALERT VIRTUO, VIRTUO bioMerieux, Inc.
K111893 07/05/2011 VITEK(R) 2 STREPTOCOCCUS TETRACYCLINE BIOMERIEUX, INC.
K112000 07/13/2011 VITEK 2 STREPTOCOCCUS PENICILLIN BIOMERIEUX, INC.
K112075 07/20/2011 VITEK 2 STRPTOCOCCUS AMPICILLIN BIOMERIEUX, INC.
K112129 07/26/2011 VITEK(R) 2 STREPTOCOCCUS CLINDAMYCIN BIOMERIEUX, INC.
K082346 08/15/2008 VITEK 2 GRAM NEGATIVE DORIPENEM BIOMERIEUX, INC.
K052311 08/24/2005 VITEK 2 GRAM NEGATIVE TIGECYCLINE BIOMERIEUX, INC.
K072668 09/21/2007 VITEK 2 GRAM POSITIVE VANCOMYCIN BIOMERIEUX, INC.
K072695 09/24/2007 VITEK 2 GRAM POSITIVE TIGECYCLINE BIOMERIEUX, INC.
K052656 09/26/2005 VITEK GRAM POSITIVE SUSCEPTIBILITY DAPTOMYCIN BIOMERIEUX, INC.
K093076 09/30/2009 VITEK 2 GRAM POSITIVE DOXCYCLINE BIOMERIEUX, INC.
K093224 10/14/2009 DENSICHECK PLUS BIOMERIEUX, INC.
K042946 10/26/2004 VITEK GRAM POSITIVE SUSCEPTIBILITY (GPS) CARD FOR RIFAMPIN BIOMERIEUX, INC.
K042963 10/27/2004 VITEK GRAM POSITIVE SUSCEPTIBILITY (GPS) CARD FOR ERTAPENEM BIOMERIEUX, INC.
K113305 11/09/2011 VITEK 2 STREPTOCOCCUS TRIMETHOPRIM/SULFAMETHOXAZOLE BIOMERIEUX, INC.
K083383 11/17/2008 VITEK 2 GRAM POSITIVE ERYTHROMYCIN FOR STREPTOCOCCUS PNEUMONIAE BIOMERIEUX, INC.
K043230 11/22/2004 VITEK GRAM NEGATIVE SUSCEPTIBILITY (GNS) CARD FOR ERTAPENEM BIOMERIEUX, INC.
K043237 11/22/2004 VITEK GRAM NEGATIVE SUSCEPTIBILITY (GNS) CARD FOR MOXIFLOXACIN BIOMERIEUX, INC.
K083536 11/28/2008 DENSICHEK PLUS BIOMERIEUX, INC.
K063597 12/04/2006 VITEK 2 GRAM POSITIVE AMOXICILLIN FOR STREPTOCOCCUS PNEUMONIAE BIOMERIEUX, INC.
K063623 12/06/2006 VITEK 2 GRAM POSITIVE MEROPENEM FOR STREPTOCOCCUS PNEUMONIAE BIOMERIEUX, INC.
K103752 12/23/2010 VITEK 2 SYSTEMS (PC) 5.02 SOFTWARE BIOMERIEUX, INC.
K193572 12/23/2019 VITEK 2 AST-Gram Negative Imipenem/Relebactam (<=0.25/4 - >=16/4 ╡g/mL) BioMerieux, Inc.
K161217 04/29/2016 VITEK 2 Gram Negative Ceftriaxone (<=0.25->=64 ug/mL) bioMerieux, Inc.
K161437 05/24/2016 VITEK 2 AST Gram Negative Cefotaxime (<=0.25 - >=64 ug/mL) BIOMERIEUX, INC.
K162076 07/27/2016 chromID MRSA bioMerieux, Inc.
K163042 10/31/2016 chromID Strepto B agar bioMerieux, Inc.
K021326 04/26/2002 VIDAS TESTOSTERONE (TES), MODEL 30 418 BIOMERIEUX, INC.
K093383 10/30/2009 NUCLISENS EASYQ ENTEROVIRUS V1.1., NUCLISENS EASYQ DIRECTOR 2.6, NUCLISENS EASYQ ANALYZER, NUCLISENS MINIMAG BIOMERIEUX, INC.
K101946 07/12/2010 VIDAS TOXO IGG AVIDITY BIOMERIEUX, INC.
K183166 11/15/2018 BacT/ALERT FA Plus; BacT/ALERT PF Plus bioMerieux, Inc.
K163083 11/03/2016 VITEK 2 AST-GN Tobramycin (/= 16 ug/mL); VITEK 2 AST-Gram Negative Tobramycin (/=16 ug/mL) bioMerieux, Inc.
DEN130013 01/02/2013 VITEK MS BIOMERIEUX, INC.
K050002 01/03/2005 VITEK 2 COMPACT BIOMERIEUX, INC.
K080107 01/15/2008 VITEK 2 GRAM NEGATIVE PIPERACILLIN/TAZOBACTAM BIOMERIEUX, INC.
K010550 02/26/2001 VIDAS TOTAL PROSTATE SPECIFIC ANTIGEN (TPSA), MODEL 30 428 BIOMERIEUX, INC.
K030950 03/26/2003 VIDAS TROPONIN I (TNI), MODEL 30 445 BIOMERIEUX, INC.
K040845 04/01/2004 VITEK 2 ESBL TEST BIOMERIEUX, INC.
K091024 04/10/2009 CHROMID MRSA AGAR, MODEL: REF 43 841 BIOMERIEUX, INC.
K091025 04/10/2009 CHROMID VRE AGAR, MODEL: REF 43 851 BIOMERIEUX, INC.
K050976 04/18/2005 VITEK 2 GRAM POSITIVE TRIMETHOPRIM/SULFAMETHOXAZOLE BIOMERIEUX, INC.
K031410 05/05/2003 VITEK 2 GRAM POSITIVE LINEZOLID FOR STREPTOCOCCUS PNEUMONIAE BIOMERIEUX, INC.
K061347 05/15/2006 VITEK 2 GRAM POSITIVE VRSA SCREEN BIOMERIEUX, INC.
K101566 06/04/2010 VITEK 2 YEAST CASPOFUNGIN BIOMERIEUX, INC.
K031865 06/17/2003 VITEK 2 GRAM POSITIVE MOXIFLOXACIN FOR STREPOCOCCUS PNEUMONIAE BIOMERIEUX, INC.
K022045 06/24/2002 VITEK GRAM POSITIVE SUSCEPTIBILITY (GPS) CARD FOR LINEZOLID BIOMERIEUX, INC.
K091899 06/25/2009 VITEK 2 GRAM NEGATIVE MEROPENEM BIOMERIEUX, INC.
K051849 07/07/2005 VITEK 2 GRAM POSITIVE ERTAPENEM FOR STREPTOCOCCUS PNEUMONIAE BIOMERIEUX, INC.
K061945 07/10/2006 VITEK 2 AST-YS FLUCONAZOLE BIOMERIEUX, INC.
K041982 07/23/2004 VITEK 2 GRAM NEGATIVE ERTAPENEM BIOMERIEUX, INC.
K032314 07/28/2003 VITEK 2 GRAM POSITIVE GATIFLOXACIN BIOMERIEUX, INC.
K032399 08/04/2003 VITEK 2 GRAM POSITIVE MOXIFLOXACIN BIOMERIEUX, INC.
K092454 08/10/2009 VITEK 2 YEAST VORICONAZOLE BIOMERIEUX, INC.
K032711 09/02/2003 VITEK GRAM NEGATIVE GATIFLOXACIN BIOMERIEUX, INC.
K032738 09/04/2003 VITEK 2 GRAM POSITIVE QUINUPRISTIN/DALFOPRISTIN BIOMERIEUX, INC.
K032766 09/05/2003 VITEK 2 GRAM POSITIVE LINEZOLID BIOMERIEUX, INC.
K032788 09/08/2003 VITEK 2 GRAM NEGATIVE GATIFLOXACIN BIOMERIEUX, INC.
K032861 09/12/2003 VITEK 2 GRAM NEGATIVE MOXIFLOXACIN BIOMERIEUX, INC.
K073083 11/01/2007 VITEK 2 GRAM NEGATIVE PIPERACILLIN BIOMERIEUX, INC.
K053097 11/03/2005 VITEK 2 GRAM POSITIVE CEFOXITIN SCREEN BIOMERIEUX, INC.
K053186 11/14/2005 VITEK 2 GRAM POSITIVE TELITHROMYCIN FOR STREPTOCOCCUS PNEUMONIAE BIOMERIEUX, INC.
K073406 12/04/2007 VITEK 2 GRAM NEGATIVE TRIMETHOPRIM/SULFAMETHOXAZOLE BIOMERIEUX, INC.
K020871 12/28/2001 VITEK 2 ANTIMIRCROBIAL SUSCEPTIBILITY TEST SYSTEM FOR LEVOFLOXACIN BIOMERIEUX, INC.
K020870 12/28/2001 VITEK 2 ANTIMICROBIAL SUSCEPTIBILITY TEST SYTEM FOR SPARFLOXACIN BIOMERIEUX, INC.
K111599 06/08/2011 VITEK 2 AST-ST LINEZOLID BIOMERIEUX, INC.
K131779 06/17/2013 VITEK 2 AST-ST TIGECYCLINE BIOMERIEUX, INC.
K111909 07/05/2011 VITEK 2 STREPTOCOCCUS INDUCIBLE CLINDAMYCIN RESISTANCE BIOMERIEUX, INC.
K212461 08/06/2021 VITEK MS PRIME bioMerieux, Inc.
K132507 08/12/2013 VITEK 2 AST ST MEROPENEM BIOMERIEUX, INC.
K132573 08/16/2013 VITEK 2 AST ST MOXIFLOXACIN, VITEK 2 AST STREPTOCOCCUS MOXIFLOXACIN BIOMERIEUX, INC.
K162950 10/24/2016 VITEK MS bioMerieux, Inc.
K080017 01/03/2008 VIDAS AFP ASSAY BIOMERIEUX, INC.
K080194 01/25/2008 VIDAS CEA (S) ASSAY BIOMERIEUX, INC.
K080469 02/21/2008 VIDAS CA 15-3 ASSAY BIOMERIEUX, INC.
K080766 03/18/2008 VIDAS RUB IGG BIOMERIEUX, INC.
K080931 04/02/2008 VIDAS C. DIFICILE TOXIN A & B (CDAB) ASSAY BIOMERIEUX, INC.
K071146 04/24/2007 VIDAS B.R.A.H.M.S. PCT ASSAY BIOMERIEUX, INC.
K072138 08/02/2007 VIDAS C. DIFFICILE TOXIN A&B (CDAB) ASSAY, MODEL: 30 118 BIOMERIEUX, INC.
K063243 10/26/2006 VIDAS TROPONIN I ULTRA (TNIU) ASSAY, MODEL 30 448 BIOMERIEUX, INC.
K073091 11/01/2007 VIDAS NT-PROBNP ASSAY, MODEL: 30 449 BIOMERIEUX, INC.
K121455 05/16/2012 BACT/ALERT FN PLUS CULTURE BOTTLE BIOMERIEUX, INC.
K020813 03/13/2002 BACT/ALERT FA CULTURE BOTTLE BIOMERIEUX, INC.
K020815 03/13/2002 BACT/ALERT FN CULTURE BOTTLE BIOMERIEUX, INC.
K020923 03/21/2002 BACT/ALERT PF CULTURE BOTTLE BIOMERIEUX, INC.
K020931 03/22/2002 BACT/ALERT SA CULTURE BOTTLE BIOMERIEUX, INC.
K021123 04/08/2002 BACT/ALERT SN CULTURE BOTTLE BIOMERIEUX, INC.
K021877 06/07/2002 MDA D-DIMER BIOMERIEUX, INC.
K030328 01/31/2003 VIDAS D-DIMER NEW (DD2) ASSAY, MODEL 30 442 BIOMERIEUX, INC.
K020810 03/13/2002 VIDAS D-DIMER NEW (DD2) ASSAY MODEL#30 442 BIOMERIEUX, INC.
K040882 04/05/2004 VIDAS D-DIMER EXCLUSION ASSAY, MODEL 30 442 BIOMERIEUX, INC.
K063261 10/30/2006 NUCLISENS EASYQ ENTEROVIRUS SYSTEM BIOMERIEUX, INC.
K113200 10/31/2011 VITEK 2 AST-GN PIPERACILLIN/TAZOBACTAM BIOMERIEUX, INC.
K080561 02/28/2008 VIDAS CA 125 II ASSAY BIOMERIEUX, INC.
K965084 12/19/1996 VIDAS PROESTERONE (PRG) (30 409) BIOMERIEUX, INC.
K122359 08/03/2012 VITEK 2 STRPTOCOCCUS CEFTRIAXONE BIOMERIEUX, INC.
K112818 09/28/2011 VIDAS D-DIMER EXCLUSION II (DEX2) BIOMERIEUX, INC.


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