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 |
|---|---|---|---|
| Mar 16, 2009 | K082346 | VITEK 2 GRAM NEGATIVE DORIPENEM bioMerieux, Inc. | LON |
| Feb 18, 2009 | K083383 | VITEK 2 GRAM POSITIVE ERYTHROMYCIN FOR STREPTOCOCCUS PNEUMONIAE bioMerieux, Inc. | LON |
| Jan 29, 2009 | K082852 | BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM-NITROFURANTOIN (GP) 4-128 UG/ML Becton, Dickinson & CO | LON |
| Dec 5, 2008 | K082913 | BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM-DOXYCYCLINE (GP) 0.25-16 UG/ML Becton, Dickinson & CO | LON |
| Nov 20, 2008 | K082538 | BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM-PHOENIX INDUCIBLE MACROLIDE RESISTANCE TEST Becton, Dickinson & CO | LON |
| Apr 30, 2008 | K080201 | VITEK 2 GRAM POSITIVE INDUCIBLE CLINDAMYCIN RESISTANCE bioMerieux, Inc. | LON |
| Mar 5, 2008 | K073589 | BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM-DAPTOMYCIN (0.0313-16 UG/ML) STEPTOCOCCUS ID/AST OR AST ONLY PHOENIX PANELS Becton, Dickinson & CO | LON |
| Feb 28, 2008 | K080107 | VITEK 2 GRAM NEGATIVE PIPERACILLIN/TAZOBACTAM bioMerieux, Inc. | LON |
| Jan 23, 2008 | K073406 | VITEK 2 GRAM NEGATIVE TRIMETHOPRIM/SULFAMETHOXAZOLE bioMerieux, Inc. | LON |
| Jan 14, 2008 | K073433 | BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM-PIPERACILLIN (GN) -128 UG/ML Becton, Dickinson & CO | LON |
| Dec 10, 2007 | K073083 | VITEK 2 GRAM NEGATIVE PIPERACILLIN bioMerieux, Inc. | LON |
| Nov 16, 2007 | K072695 | VITEK 2 GRAM POSITIVE TIGECYCLINE bioMerieux, Inc. | LON |
| Oct 15, 2007 | K072668 | VITEK 2 GRAM POSITIVE VANCOMYCIN bioMerieux, Inc. | LON |
| Sep 24, 2007 | K070809 | BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM-MINOCYCLINE (GP) 1-32 UG/ML Becton, Dickinson & CO | LON |
| Sep 12, 2007 | K072038 | VITEK 2 GRAM NEGATIVE LEVOFLOXACIN bioMerieux, Inc. | LON |
| Aug 20, 2007 | K071623 | BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM, AMPICILLIN-SULBACTAM (GN) 1/0.5-32/16 UG/ML Becton, Dickinson & CO | LON |
| Aug 20, 2007 | K071317 | MICROSCAN SYNERGIES PLUS GRAM POSITIVE MIC/COMBO PANELS NEW ANTIMICROBIAL-GENTAMICIN SYNERGY SCREEN Dade Behring, Inc. | LON |
| Jul 18, 2007 | K070346 | DADE BEHRING LABPRO ALERT SOFTWARE SYSTEM Dade Behring, Inc. | LON |
| Jun 26, 2007 | K071268 | MICROSCAN SYNERGIES PLUS GRAM POSITIVE MIC/COMBO PANELS WITH TETRACYCLINE Dade Behring, Inc. | LON |
| May 21, 2007 | K071076 | SYNERGIES PLUS GRAM-POSITIVE MIC/COMBO PANELS Dade Behring, Inc. | LON |
| May 11, 2007 | K070860 | MICROSCAN SYNERGIES PLUS GRAM-POSITIVE MIC/COMBO PANELS WITH CLINDAMYCIN Dade Behring, Inc. | LON |
| Mar 7, 2007 | K063486 | BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM MINOCYCLINE (1-32 UG/ML) GRAM NEGATIVE ID/AST OR AST ONLY Becton, Dickinson & CO | LON |
| Feb 14, 2007 | K063824 | BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM - AZTREONAM (GN) 0.5-64UG/ML Becton, Dickinson & CO | LON |
| Feb 9, 2007 | K063811 | BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM - CEFAZOLIN (GN) 0.5-32UG/ML Becton, Dickinson & CO | LON |
| Feb 8, 2007 | K063564 | MICROSCAN SYNERGIES PLUS GRAM-POSITIVE MIC/COMBO PANELS WITH CHLORAMPHENICOL (4-16 UG/ML) Dade Behring, Inc. | LON |
| Jan 29, 2007 | K063300 | BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM - CEFPODOXIME (GN) 0.125-8UG/ML Becton, Dickinson & CO | LON |
| Jan 19, 2007 | K063597 | VITEK 2 GRAM POSITIVE AMOXICILLIN FOR STREPTOCOCCUS PNEUMONIAE bioMerieux, Inc. | LON |
| Jan 11, 2007 | K063623 | VITEK 2 GRAM POSITIVE MEROPENEM FOR STREPTOCOCCUS PNEUMONIAE bioMerieux, Inc. | LON |
| Jan 11, 2007 | K063573 | BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM-CEFTAZIDIME (GN) 0.5-64 UG/ML Becton, Dickinson & CO | LON |
| Dec 21, 2006 | K063492 | VITEK 2 GRAM POSITIVE ERYTHROMYCIN FOR STREPTOCOCCUS PNEUMONIAE bioMerieux, Inc. | LON |
| Dec 8, 2006 | K063366 | MICROSCAN SYNERGIES PLUS GRAM-POSITIVE MIC/COMBO PANEL WITH SYNERCID (0.12-2UG/ML 5DILUTION BREAKPOINT SEQUENCE Dade Behring, Inc. | LON |
| Dec 8, 2006 | K063365 | SYNERGIES PLUS GRAM-POSITIVE MIC/COMBO PANELS WITH GENTAMICIN (0.06-32MG/ML LONG DILUTION SEQUENCE Dade Behring, Inc. | LON |
| Dec 8, 2006 | K063301 | BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM - CEFEPIME (GN) 0.5-64UG/ML Becton, Dickinson & CO | LON |
| Nov 21, 2006 | K062945 | BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM - ERTAPENEM (GN) 0.25-32 UG/ML Becton, Dickinson & CO | LON |
| Nov 20, 2006 | K062938 | MICROSCAN SYNERGIES PLUS GRAM-POSITIVE MIC/COMBO PANELS WITH NITROFURANTOIN (2 - 256 UG/ML Dade Behring, Inc. | LON |
| Nov 15, 2006 | K062944 | BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM - CEFTRIAXONE (GN) 0.5-64UG/ML Becton, Dickinson & CO | LON |
| Oct 24, 2006 | K062687 | BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEN - TICARCILLIN-CLAVULANATE (GN) 1/2 - 128/2UG/ML Becton, Dickinson & CO | LON |
| Oct 20, 2006 | K062705 | SYNERGIES PLUS GRAM-POSITIVE MIC/COMBO PANELS WITH LINEZOLID Dade Behring, Inc. | LON |
| Oct 5, 2006 | K062680 | BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM - TICARCILLIN (GN) 1-128 UG/ML Becton, Dickinson & CO | LON |
| Sep 13, 2006 | K062207 | BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM - CEFUROXIME (GN) 1-64 UG/ML Becton, Dickinson & CO | LON |
| Sep 8, 2006 | K062206 | BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM - MOXIFLOXACIN (STREP) 0.0625 - 8UG/ML Becton, Dickinson & CO | LON |
| Aug 18, 2006 | K061869 | BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM-PIPERACILLIN-TAZOBACTAM (GP) 1/4-128/4 UG/ML Becton, Dickinson & CO | LON |
| Aug 10, 2006 | K061867 | BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM-CEFAZOLIN (GN) 0.5-32 UG/ML Becton, Dickinson & CO | LON |
| Jul 28, 2006 | K061673 | BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM-AMOXICILLIN-CLAVULANATE(GP) 0.25/0.12 -32/16 UG/ML Becton, Dickinson & CO | LON |
| Jul 3, 2006 | K061327 | BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM-AMOXICILLIN-CLAVULANATE (GN) 0.5/0.25-32/16 UG/ML, AMPICILLIN-SULBACTAM (GN) 0. Becton, Dickinson & CO | LON |
| Jun 20, 2006 | K061347 | VITEK 2 GRAM POSITIVE VRSA SCREEN bioMerieux, Inc. | LON |
| Jun 7, 2006 | K061355 | BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM - AMPICILLIN (GN) 0.5-32 UG/ML Becton, Dickinson & CO | LON |
| May 25, 2006 | K060324 | BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM FOR USE WITH THE ANTIMICROBIAL AGENT GATIFLOXACIN 0.25-8 UG/ML - GRAM-NEGATIVE Becton, Dickinson & CO | LON |
| May 11, 2006 | K060558 | BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM CEPHALOTHIN - GN 1 - 64 UG/ML Becton, Dickinson & CO | LON |
| Apr 26, 2006 | K060447 | BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM -NITROFURANTOIN (GN) 8-512 UG/ML, TRIMETHOPRIM-SULFAMETHOXAZOLE (GN) Becton, Dickinson & CO | LON |
Free CSV: newest 100 rows. Paid plans export up to 1,000 or 10,000 rows.