Panels › Microbiology › Product code LON · Class 2
System, Test, Automated, Antimicrobial Susceptibility, Short Incubation
Regulation 866.1645
4510(k)s in 12 months (291 all time)
6recalls in 12 months (240 all time)
161recalls that name a 510(k)
Top companies in LON
| Company | 510(k)s | Recalls |
|---|---|---|
| BIOMERIEUX | 116 | 192 |
| Becton Dickinson & Company | 107 | 29 |
| Dade Behring, Inc. | 37 | 1 |
| Becton, Dickinson and Co. | 15 | 0 |
| Siemens Healthcare Diagnostics | 1 | 13 |
| Bd Diagnostic Systems | 3 | 0 |
| Beckman Coulter, Inc. | 1 | 2 |
| Biomérieux, Inc. | 2 | 0 |
| Copan Wasp Srl | 2 | 0 |
| Dade Microscan, Inc. | 2 | 0 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Feb 9, 2018 | K173523 | BD Phoenix Automated Microbiology System - GN Meropenem-vaborbactam (0.125/8-32/8 ug/mL) Becton, Dickinson and Company | LON |
| Jan 5, 2018 | K173252 | BD Phoenix Automated Microbiology System - GN Ceftolozane/tazobactam (0.25/4-32/4 ug/mL) Becton, Dickinson and Company | LON |
| Dec 19, 2017 | K172944 | VITEK 2 AST-GN Ceftazidime/Avibactam <=0.12 >=16 µg/mL bioMerieux, Inc. | LON |
| Dec 8, 2017 | K172731 | VITEK 2 AST-GN Amikacin (<=1 ->=64 ug/mL) bioMerieux, Inc. | LON |
| Jun 21, 2017 | K162737 | VITEK 2 AST-GN Ciprofloxacin (<=0.06->=4µg/mL) bioMerieux, Inc. | LON |
| Mar 21, 2017 | K163637 | BD Phoenix Automated Microbiology System - GN Ceftazidime/avibactam (0.25/4- 32/4ug/mL) Becton Dickinson & Company | LON |
| Mar 13, 2017 | K163563 | VITEK 2 AST-GN Gentamicin (<=1 >=16 µg/mL) bioMerieux, Inc. | LON |
| Feb 16, 2017 | K161437 | VITEK 2 AST Gram Negative Cefotaxime (<=0.25 - >=64 ug/mL) bioMerieux, Inc. | LON |
| Feb 13, 2017 | K161510 | VTEK 2 AST-GN Ceftolozane/Tazobactam (<=0.25 - >= 32 mcg/mL) bioMerieux, Inc. | LON |
| Feb 1, 2017 | K163083 | VITEK 2 AST-GN Tobramycin (</=1->/= 16 ug/mL); VITEK 2 AST-Gram Negative Tobramycin (</=1->/=16 ug/mL) bioMerieux, Inc. | LON |
| Jan 24, 2017 | K163006 | VITEK 2 AST-GN Tigecycline (<0.5->8 ug/mL) bioMerieux, Inc. | LON |
| Jan 12, 2017 | K161217 | VITEK 2 Gram Negative Ceftriaxone (<=0.25->=64 ug/mL) bioMerieux, Inc. | LON |
| Jul 20, 2016 | K161227 | VITEK 2 AST-GN Cefepime (<=0.12->=32 ug/mL) bioMerieux, Inc. | LON |
| Apr 15, 2016 | K152075 | VITEK 2 AST-Gram Negative Ertapenem (<=0.12 - >=8 ug/mL) bioMerieux, Inc. | LON |
| Jan 15, 2016 | K151320 | BD Phoenix Automated Microbiology System-Ertapenem 0.0625-8 mcg/ml Becton, Dickinson and Company | LON |
| Oct 28, 2014 | K142170 | BD PHOENIX AUTOMATED MICROBIOLOGY SYSTESM - TIGECYCLINE (0.313-4UG/ML) GP Becton, Dickinson and Company | LON |
| Jun 20, 2014 | K141149 | VITEK 2 AST GP CEFTAROLINE bioMerieux, Inc. | LON |
| Jun 2, 2014 | K140468 | BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM - CEFTAROLINE (0.625-4 UG/ML) Becton, Dickinson and Company | LON |
| Feb 14, 2014 | K132909 | BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM TIGECYCLINE (0.25-16 UG/ML) Becton, Dickinson and Company | LON |
| Dec 27, 2013 | K132674 | BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM- MEROPENEM (0.125-32 UG/ML) Becton, Dickinson and Company | LON |
| Nov 15, 2013 | K132507 | VITEK 2 AST ST MEROPENEM bioMerieux, Inc. | LON |
| Oct 10, 2013 | K131779 | VITEK 2 AST-ST TIGECYCLINE bioMerieux, Inc. | LON |
| Sep 13, 2013 | K132573 | VITEK 2 AST ST MOXIFLOXACIN, VITEK 2 AST STREPTOCOCCUS MOXIFLOXACIN bioMerieux, Inc. | LON |
| Jul 10, 2013 | K131331 | BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM - VANCOMYCIN (0.5-32 UG/ML) Becton, Dickinson & CO | LON |
| Jun 27, 2013 | K123404 | BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM- IMIPENEM (0.0625-32 UG/ML) Becton, Dickinson & CO | LON |
| Jun 26, 2013 | K123266 | BD PHOENIX AUTOMATED MICROIOLOGY SYSTEM- ERTAPENEM 0.0625-8 UG/ML-GN Becton, Dickinson and Company | LON |
| Nov 20, 2012 | K121546 | VITEK 2 GRAM NEGATIVE DOXYCYCLINE bioMerieux, Inc. | LON |
| Nov 19, 2012 | K121100 | VITEK 2 AST STREPTOCOCUS VANCOMYCIN bioMerieux, Inc. | LON |
| Oct 15, 2012 | K122547 | GRAM POSTITVE CLINDAMYCIN bioMerieux, Inc. | LON |
| Aug 28, 2012 | K122359 | VITEK 2 STRPTOCOCCUS CEFTRIAXONE bioMerieux, Inc. | LON |
| Aug 16, 2012 | K121863 | VITEK 2 AST-ST CEFOTAXIME bioMerieux, Inc. | LON |
| Aug 7, 2012 | K113783 | VITEK 2 AST- GRAM POSTIVE PENICILLIN FOR STREPTOCOCCUS PNEUMONIAE bioMerieux, Inc. | LON |
| Jun 29, 2012 | K113200 | VITEK 2 AST-GN PIPERACILLIN/TAZOBACTAM bioMerieux, Inc. | LON |
| Feb 28, 2012 | K111893 | VITEK(R) 2 STREPTOCOCCUS TETRACYCLINE bioMerieux, Inc. | LON |
| Feb 17, 2012 | K111976 | VITEK 2 STREPTOCOCCUS ERYTHROMYCIN bioMerieux, Inc. | LON |
| Feb 10, 2012 | K113305 | VITEK 2 STREPTOCOCCUS TRIMETHOPRIM/SULFAMETHOXAZOLE bioMerieux, Inc. | LON |
| Nov 30, 2011 | K110106 | VITEK 2 GRAM NEGATIVE TRIMETHOPRIM/SULFAMETHOAZOLE bioMerieux, Inc. | LON |
| Oct 26, 2011 | K112000 | VITEK 2 STREPTOCOCCUS PENICILLIN bioMerieux, Inc. | LON |
| Oct 18, 2011 | K111909 | VITEK 2 STREPTOCOCCUS INDUCIBLE CLINDAMYCIN RESISTANCE bioMerieux, Inc. | LON |
| Oct 14, 2011 | K103752 | VITEK 2 SYSTEMS (PC) 5.02 SOFTWARE bioMerieux, Inc. | LON |
| Oct 3, 2011 | K112228 | VITEK 2 STREPTOCOCCUS LEVOFLOXACIN bioMerieux, Inc. | LON |
| Sep 27, 2011 | K112129 | VITEK(R) 2 STREPTOCOCCUS CLINDAMYCIN bioMerieux, Inc. | LON |
| Sep 15, 2011 | K112075 | VITEK 2 STRPTOCOCCUS AMPICILLIN bioMerieux, Inc. | LON |
| Aug 12, 2011 | K111599 | VITEK 2 AST-ST LINEZOLID bioMerieux, Inc. | LON |
| Oct 21, 2010 | K093076 | VITEK 2 GRAM POSITIVE DOXCYCLINE bioMerieux, Inc. | LON |
| Nov 9, 2009 | K093224 | DENSICHECK PLUS bioMerieux, Inc. | LON |
| Oct 23, 2009 | K092919 | MICROSCAN SYNERGIES PLUS MIC/COMBO PANELS, MODEL B1025 Siemens Healthcare Diagnostics | LON |
| Sep 11, 2009 | K083536 | DENSICHEK PLUS bioMerieux, Inc. | LON |
| Aug 14, 2009 | K091899 | VITEK 2 GRAM NEGATIVE MEROPENEM bioMerieux, Inc. | LON |
| Jun 18, 2009 | K091126 | VITEK 2 GRAM POSITIVE DAPTOMYCIN bioMerieux, Inc. | LON |
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