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 |
|---|---|---|---|
| Apr 14, 2006 | K060257 | BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM - CEFOXITIN - 0.5-64 UG/ML Becton, Dickinson & CO | LON |
| Apr 12, 2006 | K060444 | BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM - CEFEPIME (GN) , CEFTRIAXONE (GN), CEFOTAXIME (GN), 0.5-64 UG/ML Becton, Dickinson & CO | LON |
| Apr 12, 2006 | K060217 | BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM - MOXIFLOXACIN-0.125-8 AND CIPROFLOXACIN-0.25 - 4 UG/ML Becton, Dickinson & CO | LON |
| Mar 29, 2006 | K060493 | BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM - VANCOMYCIN-GP DETECTION OF VRSA. Becton, Dickinson & CO | LON |
| Mar 23, 2006 | K060312 | MICROSCAN SYNERGIES PLUS GRAM-POSITIVE MIC/COMBO PANELS WITH VANCOMYCIN (0.25-64 UG/ML) Dade Behring, Inc. | LON |
| Mar 17, 2006 | K060218 | BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM - ERYTHROMYCIN-0.0625-8 UG/ML, AND QUINUPRISTIN/DALFOPRISTIN-0.25-4 UG/ML Becton, Dickinson & CO | LON |
| Mar 9, 2006 | K060214 | BD PHOENIX AUTOMATED MIRCROBIOLOGY SYSTEM TETRACYCLINE-GN 0.5-16 UG/ML AND GP 0.5-16 UG/ML Becton, Dickinson & CO | LON |
| Feb 24, 2006 | K053504 | MICROSCAN SYNERGIES PLUS GRAM-POSITIVE MIC/COMBO PANELS WITH ERYTHROMYCIN (0.12-16 UG/ML) Dade Behring, Inc. | LON |
| Feb 3, 2006 | K060088 | MICROSCAN SYNERGIES PLUS GRAM POSITIVE MIC/COMBO PANELS - AMPICILLIN Dade Behring, Inc. | LON |
| Dec 22, 2005 | K053241 | BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM - CEFOXITIN GP 1-32 G/ML Becton, Dickinson & CO | LON |
| Dec 14, 2005 | K053097 | VITEK 2 GRAM POSITIVE CEFOXITIN SCREEN bioMerieux, Inc. | LON |
| Dec 1, 2005 | K053186 | VITEK 2 GRAM POSITIVE TELITHROMYCIN FOR STREPTOCOCCUS PNEUMONIAE bioMerieux, Inc. | LON |
| Nov 7, 2005 | K052656 | VITEK GRAM POSITIVE SUSCEPTIBILITY DAPTOMYCIN bioMerieux, Inc. | LON |
| Oct 26, 2005 | K052346 | SYNERGIES PLUS GRAM-POSITIVE MIC/COMBO PANELS Dade Behring, Inc. | LON |
| Oct 5, 2005 | K052270 | BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM - CEFUROXIME (STREP) 0.125 - 4UG/ML Becton, Dickinson & CO | LON |
| Oct 3, 2005 | K052269 | BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM -CIPROFLOXACIN GN Becton, Dickinson & CO | LON |
| Sep 30, 2005 | K052250 | BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM - TOBRAMYCIN (GP) 0.5-16UG/ML Becton, Dickinson & CO | LON |
| Sep 29, 2005 | K052311 | VITEK 2 GRAM NEGATIVE TIGECYCLINE bioMerieux, Inc. | LON |
| Aug 16, 2005 | K051849 | VITEK 2 GRAM POSITIVE ERTAPENEM FOR STREPTOCOCCUS PNEUMONIAE bioMerieux, Inc. | LON |
| Aug 5, 2005 | K051689 | BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM - DAPTOMYCIN 0.125 - 32 UG/ML Becton, Dickinson & CO | LON |
| Jul 27, 2005 | K051478 | MICROSCAN SYNERGIES PLUS GRAM POSITIVE MIC/COMBO PANELS - RIFAMPIN Dade Behring, Inc. | LON |
| Jul 25, 2005 | K051350 | SYNERGIES PLUS GRAM-POSITIVE MIC/COMBO PANELS Dade Behring, Inc. | LON |
| Jul 14, 2005 | K051692 | BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM - AMOXICILLIN (STREP) 0.0313 - 32 UG/ML Becton, Dickinson & CO | LON |
| Jul 12, 2005 | K051311 | MICROSCAN SYNERGIES PLUS GRAM POSITIVE MINIMUM INHIBITORY CONCENTRATION/COMBO PANELS - LEVOFLOXACIN Dade Behring, Inc. | LON |
| Jul 11, 2005 | K051272 | BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM - CLINDAMYCIN (STREP) 0.03125 -4 UG/ML Becton, Dickinson & CO | LON |
| Jul 5, 2005 | K051266 | BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM - LINEZOLID (STREP) 0.25 - 16UG/ML Becton, Dickinson & CO | LON |
| Jun 24, 2005 | K051204 | BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM CEFEPIME (STREP) 0.0625-4UG/ML Becton, Dickinson & CO | LON |
| Jun 21, 2005 | K051183 | BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM - GATIFLOXACIN (STREP) 0.0625 -8UG/ML Becton, Dickinson & CO | LON |
| Jun 15, 2005 | K051109 | BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM - ERYTHROMYCIN (STREP) 0.0156 - 4UG/ML Becton, Dickinson & CO | LON |
| Jun 3, 2005 | K051138 | BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM - CEFTRIAXONE (STREP) 0.0625 - 4UG/ML Becton, Dickinson & CO | LON |
| May 27, 2005 | K050946 | BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM-MEROPENEM (STREP) 0.03125-2 UG/ML Becton, Dickinson & CO | LON |
| May 24, 2005 | K050982 | BD PHONIX AUTOMATED MICROBIOLOGY SYSTEM - CEFOTAXIME STREP (0.0625-4UG/ML) Becton, Dickinson & CO | LON |
| May 23, 2005 | K050976 | VITEK 2 GRAM POSITIVE TRIMETHOPRIM/SULFAMETHOXAZOLE bioMerieux, Inc. | LON |
| May 20, 2005 | K050865 | BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM-TRIMETHOPRIM-SULFAMETHOXAZOLE 0.0625/1.2-16/304 UG/ML Becton, Dickinson & CO | LON |
| May 12, 2005 | K050881 | BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM - TETRACYCLINE (STREP) 0.0625 - 16 UG/ML Becton, Dickinson & CO | LON |
| May 12, 2005 | K050816 | VITEK 2 GRAM POSITIVE MEROPENEM bioMerieux, Inc. | LON |
| May 12, 2005 | K050780 | BD PHOENIXTM AUTOMATED MICROBIOLOGY SYSTEM - PENICILLIN (STREP) 0.156 -32 UG/ML Becton, Dickinson & CO | LON |
| Apr 29, 2005 | K050747 | BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM, LEVOFLOXACIN (STREP) 0.25-16 UG/ML Becton, Dickinson & CO | LON |
| Apr 29, 2005 | K050745 | BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM, VANCOMYCIN (STREP) 0.0625 -32 UG/ML Becton, Dickinson & CO | LON |
| Apr 14, 2005 | K050555 | BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM - CEFAZOLIN (GP) 2-32 UG/ML Becton, Dickinson & CO | LON |
| Mar 22, 2005 | K050400 | BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM - CEPHALOTHIN (GP) 0.5-64 UG/ML Becton, Dickinson & CO | LON |
| Mar 15, 2005 | K043458 | BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM - CEFOTETAN (GN) 2-64 UG/ML Becton, Dickinson & CO | LON |
| Feb 28, 2005 | K050089 | BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM - AMPICILLIN-SULBACTAM (GP) 2-32 UG/ML Becton, Dickinson & CO | LON |
| Feb 28, 2005 | K050075 | VITEK 2 GRAM POSITIVE DAPTOMYCIN bioMerieux, Inc. | LON |
| Feb 18, 2005 | K050076 | VITEK 2 GRAM POSITIVE ERTAPENEM bioMerieux, Inc. | LON |
| Feb 17, 2005 | K050002 | VITEK 2 COMPACT bioMerieux, Inc. | LON |
| Jan 21, 2005 | K043389 | BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM -AMPICILLIN-SULBACTAM (GN) 0.5/0.25-32/16UG/ML Becton, Dickinson & CO | LON |
| Dec 30, 2004 | K043230 | VITEK GRAM NEGATIVE SUSCEPTIBILITY (GNS) CARD FOR ERTAPENEM bioMerieux, Inc. | LON |
| Dec 23, 2004 | K043237 | VITEK GRAM NEGATIVE SUSCEPTIBILITY (GNS) CARD FOR MOXIFLOXACIN bioMerieux, Inc. | LON |
| Dec 13, 2004 | K042963 | VITEK GRAM POSITIVE SUSCEPTIBILITY (GPS) CARD FOR ERTAPENEM bioMerieux, Inc. | LON |
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