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 |
|---|---|---|---|
| Dec 7, 2004 | K042946 | VITEK GRAM POSITIVE SUSCEPTIBILITY (GPS) CARD FOR RIFAMPIN bioMerieux, Inc. | LON |
| Dec 2, 2004 | K042932 | BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM-PIPERACILLIN-TAZOBACTAM 0.5/4-128/4 UG/ML Becton, Dickinson & CO | LON |
| Sep 14, 2004 | K041982 | VITEK 2 GRAM NEGATIVE ERTAPENEM bioMerieux, Inc. | LON |
| Aug 12, 2004 | K041572 | BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM-PIPERCILLIN (GN) 0.5-128 UG/ML Becton, Dickinson and Co. | LON |
| Aug 3, 2004 | K041384 | BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM - CEFTAZIDIME - GRAM NEGATIVE Becton, Dickinson & CO | LON |
| Jun 8, 2004 | K040845 | VITEK 2 ESBL TEST bioMerieux, Inc. | LON |
| May 28, 2004 | K033458 | BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM - CONFIRMATORY ESBL TEST Becton, Dickinson & CO | LON |
| May 14, 2004 | K040716 | BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM-PENICILLIN (GP) 0.0625-32 UG/ML Becton, Dickinson & CO | LON |
| Apr 9, 2004 | K033907 | BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM - TRIMETHOPRIM-SULFAMETHOXAZOLE 0.5/9.5 - 16/304 UG/ML Becton, Dickinson & CO | LON |
| Apr 9, 2004 | K033362 | BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM- CEFUROXIME GRAM NEGATIVE Becton, Dickinson & CO | LON |
| Apr 2, 2004 | K031601 | MICROSCAN SYNERGIES PLUS GRAM NEGATIVE MIC/COMBO PANELS WITH CEPHALOTHIN (0.5-32 UG/ML) Dade Behring, Inc. | LON |
| Mar 19, 2004 | K040099 | BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM Becton, Dickinson & CO | LON |
| Mar 11, 2004 | K040106 | BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM -- AMPICILLIN -- GRAM POSITIVE Becton, Dickinson & CO | LON |
| Mar 1, 2004 | K032675 | BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM-CEFEPIME (GN) 0.5-65 UG/ML Becton, Dickinson & CO | LON |
| Feb 27, 2004 | K040006 | BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM-LINEZOLID-GRAM POSITIVE Becton, Dickinson & CO | LON |
| Feb 3, 2004 | K033889 | BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM FOR USE WITH THE ANTIMICROBIAL AGENT CHLORAMPHENICOL 1-32 UG/ML GRAM POSITIVE Becton, Dickinson & CO | LON |
| Feb 3, 2004 | K033784 | BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM - ERYTHROMYCIN 0.0625-8 UG/ML Becton, Dickinson & CO | LON |
| Jan 14, 2004 | K033560 | BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM - CEFTAZIDIME 0.5-64 UG/ML-GRAM-NEGATIVE ID/AST OR AST ONLY PHOENIX PANELS Becton, Dickinson & CO | LON |
| Jan 14, 2004 | K033557 | BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM - TICARCILLIN/CLAVULANATE-GRAM NEGATIVE Becton, Dickinson & CO | LON |
| Dec 19, 2003 | K033558 | BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM - AZTREONAM 0.5-64 UG/ML-GRAM-NEGATIVE ID/AST OR AST ONLY PHOENIX PANELS Becton, Dickinson & CO | LON |
| Nov 26, 2003 | K033482 | MICROSCAN SYNERGIES PLUS GRAM NEGATIVE MIC/COMBO PANELS WITH AMPICILLIN (0.25-128 UG/ML) Dade Behring, Inc. | LON |
| Nov 26, 2003 | K033064 | MYCOPLASMA IGG Trinity Biotech USA | LON |
| Nov 12, 2003 | K032861 | VITEK 2 GRAM NEGATIVE MOXIFLOXACIN bioMerieux, Inc. | LON |
| Nov 4, 2003 | K032788 | VITEK 2 GRAM NEGATIVE GATIFLOXACIN bioMerieux, Inc. | LON |
| Oct 31, 2003 | K032766 | VITEK 2 GRAM POSITIVE LINEZOLID bioMerieux, Inc. | LON |
| Oct 31, 2003 | K032738 | VITEK 2 GRAM POSITIVE QUINUPRISTIN/DALFOPRISTIN bioMerieux, Inc. | LON |
| Oct 31, 2003 | K032711 | VITEK GRAM NEGATIVE GATIFLOXACIN bioMerieux, Inc. | LON |
| Oct 6, 2003 | K032655 | BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM-CEFTRIAXONE 0.5-64 UG/ML Becton, Dickinson & CO | LON |
| Sep 29, 2003 | K032275 | BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM-IMIPENEM 1-16 UG/ML GRAM-NEGATIVE ID/AST OR AST ONLY PHOENIX PANELS Becton, Dickinson & CO | LON |
| Sep 22, 2003 | K032299 | BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM,-AMPICILLIN 0.5.-32 UG/ML Becton, Dickinson & CO | LON |
| Sep 17, 2003 | K032567 | BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM-CEFOXITIN-GRAM NEGATIVE Becton, Dickinson & CO | LON |
| Sep 11, 2003 | K032153 | BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM CEFOTAXIME 0.5-64 UG/ML Bd Diagnostic Systems | LON |
| Sep 10, 2003 | K032399 | VITEK 2 GRAM POSITIVE MOXIFLOXACIN bioMerieux, Inc. | LON |
| Aug 27, 2003 | K031984 | BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM-TICARCILLIN-1-128 UG/ML Becton, Dickinson & CO | LON |
| Aug 22, 2003 | K032314 | VITEK 2 GRAM POSITIVE GATIFLOXACIN bioMerieux, Inc. | LON |
| Aug 18, 2003 | K032131 | BD AUTOMATED MICROBIOLOGY SYSTEM TETRACYCLINE - GP 0.5-16 UG/ML-GRAM POSITIVE ID/AST OR AST ONLY PHOENIX PANELS Becton, Dickinson & CO | LON |
| Aug 13, 2003 | K031865 | VITEK 2 GRAM POSITIVE MOXIFLOXACIN FOR STREPOCOCCUS PNEUMONIAE bioMerieux, Inc. | LON |
| Aug 6, 2003 | K031943 | BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM - CEPHALOTHIN (GN) 1-64 UG/ML Becton, Dickinson & CO | LON |
| Jul 31, 2003 | K031602 | MICROSCAN SYNERGIES PLUS GRAM NEGATIVE MIC/COMBO PANELS WITH NITROFURANTOIN (1-256 UG/ML) Dade Behring, Inc. | LON |
| Jul 30, 2003 | K031699 | BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM - TRIMETHOPRIM-SULFAMETHOXAZOLE 0.5/9.5-16/304UG/ML Becton, Dickinson & CO | LON |
| Jul 21, 2003 | K031912 | BD PHOENIX AUTOMATED MICRBIOLOGY SYSTEM AMOXICILLIN/CLAVUALANTE 0.5/0.25-32/16 UG/ML Becton, Dickinson & CO | LON |
| Jul 16, 2003 | K031679 | BD PHONENIX AUTOMATED MICROBIOLOGY SYSTEM Becton, Dickinson & CO | LON |
| Jul 11, 2003 | K031589 | BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM-NITROFURANTOIN GRAM POSITIVE Becton, Dickinson & CO | LON |
| Jul 10, 2003 | K031530 | BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM-NITROFURANTOIN-8-512 UG/ML Becton, Dickinson & CO | LON |
| Jul 10, 2003 | K031410 | VITEK 2 GRAM POSITIVE LINEZOLID FOR STREPTOCOCCUS PNEUMONIAE bioMerieux, Inc. | LON |
| Jun 6, 2003 | K031429 | BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM-MEROPENEM 0.25-16 UG/ML Bd Diagnostic Systems | LON |
| Jun 2, 2003 | K031306 | BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM - MOXIFLOXACIN GRAM POSITIVE Becton, Dickinson & CO | LON |
| May 16, 2003 | K030986 | BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM TRIMETHOPRIM - GN 0.5-16 UG/ML Becton, Dickinson & CO | LON |
| Apr 1, 2003 | K030677 | BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM-VANCOMYCIN GRAM POSITIVE Becton, Dickinson & CO | LON |
| Mar 21, 2003 | K030579 | BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM-NALIDIXIC ACID - 2-32 UG/ML Becton, Dickinson & CO | LON |
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