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 28, 2003 | K030091 | BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM - NORFLOXACIN 0.25 - 16 UG/ML Bd Diagnostic Systems | LON |
| Feb 10, 2003 | K024153 | BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM - TETRACYCLINE - 0.5-16 UG/ML Becton, Dickinson & CO | LON |
| Jan 31, 2003 | K024152 | BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM - RIFAMPIN 0.25-32 UG/ML Becton, Dickinson & CO | LON |
| Jan 24, 2003 | K023568 | BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM Becton, Dickinson & CO | LON |
| Jan 8, 2003 | K023895 | BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM - CIPROFLOXACIN GN Becton, Dickinson & CO | LON |
| Dec 24, 2002 | K023634 | BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM-GENTAMICIN GN (0.25-16UG/ML) Becton, Dickinson & CO | LON |
| Dec 23, 2002 | K023527 | BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM - NORFLOXACIN - 0.25-16 UG/ML Becton, Dickinson & CO | LON |
| Dec 20, 2002 | K023858 | BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM Becton, Dickinson & CO | LON |
| Dec 16, 2002 | K023361 | MICROSCAN SYNERGIES PLUS GRAM NEGATIVE MIC/COMBO PANELS WITH GATIFLOXACIN (0.004-16 UG/ML) Dade Behring, Inc. | LON |
| Dec 13, 2002 | K023541 | MICROSCAN SYNERGIES PLUS GRAM NEGATIVE MIC/COMBO PANELS WITH MOXIFLOXACIN (0.004-16UG/ML) Dade Behring, Inc. | LON |
| Nov 12, 2002 | K023444 | BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM-AMIKACIN-0.5-64 UG/ML Becton, Dickinson & CO | LON |
| Nov 12, 2002 | K023301 | BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM Becton, Dickinson & CO | LON |
| Oct 31, 2002 | K023273 | BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM - GENTAMICIN 0.25 - 16 UG/ML Becton, Dickinson & CO | LON |
| Aug 15, 2002 | K022045 | VITEK GRAM POSITIVE SUSCEPTIBILITY (GPS) CARD FOR LINEZOLID bioMerieux, Inc. | LON |
| Aug 12, 2002 | K022172 | BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM Becton, Dickinson & CO | LON |
| Aug 1, 2002 | K021954 | BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM-CLINDAMYCIN 0.125-8.0MCG/ML Becton, Dickinson & CO | LON |
| Jul 25, 2002 | K022129 | BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM MOXIFLOXACIN 0.125-8 UG/ML Becton, Dickinson & CO | LON |
| Jul 17, 2002 | K020413 | MICROSCAN SYNERGIES PLUS DRIED GRAM NEGATIVE MIC/COMBO PANELS WITH CEFTAZIDIME (1-16 UG/ML) Dade Behring, Inc. | LON |
| Jun 11, 2002 | K020410 | MICROSCAN RAPID/S PLUS GRAM-NEGATIVE MIC/COMBO PANELS WITH CEPHALOTHIN (2-64 UG/ML) Dade Behring, Inc. | LON |
| May 23, 2002 | K020321 | BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM Becton, Dickinson & CO | LON |
| May 16, 2002 | K020398 | MICROSCAN SYNERGIES PLUS GRAM NEGATIVE MIC/COMBO PANELS WITH AMPICILLIN (0.25-128 UG/ML) Dade Behring, Inc. | LON |
| Apr 22, 2002 | K020397 | MICROSCAN SYNERGIES PLUS GRAM NEGATIVE MIC/COMBO PANELS WITH PIPERACILLIN (4-256 UG/ML) Dade Behring, Inc. | LON |
| Apr 17, 2002 | K020506 | MICROSCAN SYNERGIES PLUS GRAM-NEGATIVE MIC/COMBO PANELS WITH CEFTRIAXONE (0.5-128 UG/ML) Dade Microscan, Inc. | LON |
| Apr 17, 2002 | K020319 | MICROSCAN SYNERGIES PLUS GRAM NEGATIVE MIC/COMBO PANELS WITH AMPICILLIN/SULBACTAM (0.5/0.25-64/34 UG/ML) Dade Behring, Inc. | LON |
| Apr 4, 2002 | K020323 | BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM Becton, Dickinson & CO | LON |
| Mar 29, 2002 | K020871 | VITEK 2 ANTIMIRCROBIAL SUSCEPTIBILITY TEST SYSTEM FOR LEVOFLOXACIN bioMerieux, Inc. | LON |
| Mar 27, 2002 | K020322 | BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM Becton, Dickinson & CO | LON |
| Mar 25, 2002 | K020870 | VITEK 2 ANTIMICROBIAL SUSCEPTIBILITY TEST SYTEM FOR SPARFLOXACIN bioMerieux, Inc. | LON |
| Mar 14, 2002 | K020248 | MICROSCAN SYNERGIES PLUS GRAM NEGATIVE MIC/COMBO PANELS WITH TRIMETHOPRIM/SULFAMETHOXAZOLE (0.25/4.75-64/1216 UG/ML) Dade Behring, Inc. | LON |
| Mar 14, 2002 | K020142 | MICROSCAN SYNERGIES PLUS Dade Behring, Inc. | LON |
| Mar 6, 2002 | K020511 | MICROSCAN SYNERGIES PLUS Dade Microscan, Inc. | LON |
| Feb 19, 2002 | K020328 | MICROSCAN SYNERGIES PLUS GRAM NEGATIVE MIC/COMBO PANELS WITH CEFUROXIME (1-64 UG/ML) Dade Behring, Inc. | LON |
| Feb 6, 2002 | K020249 | MICROSCAN PLUS GRAM NEGATIVE MIC/COMBO PANELS WITH MEROPENEM (0.12-32 UG/ML) Dade Behring, Inc. | LON |
| Feb 6, 2002 | K020246 | MICROSCAN SYNERGIES PLUS GRAM NEGATIVE MIC/COMBO PANELS WITH IMIPENEM (0.25, 1-32 UG/ML) Dade Behring, Inc. | LON |
| Feb 6, 2002 | K020209 | MICROSCAN SYNERGIES PLUS GRAM NEGATIVE MIC/COMBO PANELS WITH AMIKACIN (0.25-128 UG/ML) Dade Behring, Inc. | LON |
| Feb 6, 2002 | K020185 | MICROSCAN RAPID/S PLUS GRAM-NEGATIVE MIC COMBO PANELS WITH GENTAMICIN (0.12-32 UG/ML) Dade Behring, Inc. | LON |
| Feb 6, 2002 | K020182 | MICROSCAN SYNERGIES PLUS GRAM NEGATIVE MIC/COMBO PANELS WITH NETILMICIN (0.12-32 UG/ML) Dade Behring, Inc. | LON |
| Feb 6, 2002 | K020173 | MICROSCAN SYNERGIES PLUS GRAM NEGATIVE MIC/COMBO PANELS WITH TETRACYCLINE (0.12-128 UG/ML) Dade Behring, Inc. | LON |
| Feb 6, 2002 | K020168 | MICROSCAN SYNERGIS PLUS GRAM NEGATIVE MIC/COMBO PANELS WITH TOBRAMYCIN (0.12-32 UG/ML) Dade Behring, Inc. | LON |
| Jun 2, 1989 | K891577 | SCEPTOR DATA MANAGEMENT CENTER SOFTWARE Bd Becton Dickinson Vacutainer Systems Preanalytic | LON |
| Aug 1, 1986 | K861958 | REPLIANALYZER Mct Medical, Inc. | LON |
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