Panels › Microbiology › Product code JWY · Class 2
Manual Antimicrobial Susceptibility Test Systems
Regulation 866.1640
2510(k)s in 12 months (441 all time)
0recalls in 12 months (78 all time)
77recalls that name a 510(k)
Top companies in JWY
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Jun 10, 2014 | K140985 | SENSITITRE HAEMOPHILUS/STREPTOCOCCUS PNEUMONIAE(HP) SUSCEPTIBILITY PLATES Thermo Fisher Scientific | JWY |
| Feb 27, 2014 | K133773 | SENSITITRE 18-24 HOUR MIC SUCEPTIBILITY SYSTEM Thermo Fisher Scientific | JWY |
| Oct 12, 2012 | K121002 | ETEST CEFTAROLINE bioMerieux, Inc. | JWY |
| Nov 16, 2011 | K112276 | VIZION Trek Diagnostic Systems | JWY |
| Nov 8, 2011 | K111615 | SENSITITRE 18-24 HR SUSCEPTIBILITY PLATES Trek Diagnostic Systems | JWY |
| Aug 18, 2011 | K111429 | SENSITITRE (R) HP MIC SUSCEPTIBILITY PLATE WITH CEFAROLINE (0.004-8UG/ML) AND THE SENSITITRE (R) 18-24 HOUR MIC SUSCE... Trek Diagnostic Systems, Ltd. | JWY |
| May 16, 2011 | K102535 | ETEST TELAVANCIN IN 0.002-32 UG/ML AND 0.016-256 UG/ML Biomerieux S.A., FR | JWY |
| Nov 17, 2010 | K102668 | ETEST TOBRAMYCIN 0.016-256 UG/ML AND 0.064-1024 UG/ML BIOMERIEUX, FR | JWY |
| Aug 25, 2010 | K093604 | ETEST MOXIFLOXACIN 0.002-32 UG/ML Ab Biomerieux, SE | JWY |
| Feb 25, 2010 | K093741 | SENSITIVE HAEMOPHILUS INFLUENZAE, STREPTOCOCCUS PNEUMONIA, (HP) MIC SUSCEPTIBILITY PLATES Trek Diagnostic Systems, Ltd. | JWY |
| Feb 17, 2010 | K093865 | SENSITITRE 18-24HR SUSCEPTIBILITY PLATES Trek Diagnostic Systems, Inc. | JWY |
| Dec 16, 2009 | K092445 | SENSITITRE 18-24 HOUR SUSCEPTIBILITY PLATES Trek Diagnostic Systems, Ltd. | JWY |
| Mar 24, 2009 | K083606 | SENSITITRE 18-24 HOUR SUSECEPTIBILITY PLATES Trek Diagnostic Systems, Inc. | JWY |
| Oct 24, 2008 | K081520 | SENSITITRE VIZION Trek Diagnostic Systems, Inc. | JWY |
| Aug 8, 2008 | K081182 | MICROSCAN DRIED GRAM-POSITIVE MIC/COMBO PANELS NEW ANTIMICROBIAL TEST - INDUCIBLE CLINDAMYCIN Siemens | JWY |
| Jul 24, 2008 | K081325 | ETEST DORIPENEM - ANTIMICROBIAL SUSCEPTIBILITY TEST - MIC AT 0.002-32 UG/ML Ab Biodisk, SE | JWY |
| Mar 20, 2008 | K073653 | SENSITITRE 18 - 24 HOUR SUSCEPTIBILITY PLATE Trek Diagnostic Systems, Inc. | JWY |
| Mar 13, 2008 | K073558 | SENSITITRE 18-24 SUSCEPTIBILITY PLATE Trek Diagnostic Systems, Inc. | JWY |
| Jan 22, 2008 | K073424 | SENSITITRE 18-24 HOUR SUSCEPTIBILITY PLATES Trek Diagnostic Systems, Inc. | JWY |
| Dec 20, 2006 | K062841 | SENSITITRE HAEMOPHILUS/STREPTOCOCCUS PNEUMONIAE (HP) MIC AND SUSCEPTIBILITY PLATES Trek Diagnostic Systems, Inc. | JWY |
| Nov 9, 2006 | K062839 | MODIFICATION TO SENSITITRE HAEMOPHILUS/STREPTOCOCCUS PNEUMONIAE (HP) MIC PLATE Trek Diagnostic Systems, Inc. | JWY |
| Nov 1, 2006 | K062816 | SENSITITRE HAEMOPHILUS/STREPTOCOCCUS PNEUMONIAE (HP) MIC PLATE Trek Diagnostic Systems, Inc. | JWY |
| Oct 26, 2006 | K062783 | SENSITITRE HAEMOPHILUS/STREPTOCOCCUS PNEUMONIAE (HP) MIC PLATE Trek Diagnostic Systems, Inc. | JWY |
| Oct 20, 2006 | K062722 | SENSITITRE HAEMOPHILUS/STREPTOCOCCUS PNEUMONIAE (HP) MIC PLATE Trek Diagnostic Systems, Inc. | JWY |
| Oct 13, 2006 | K062681 | SENSITITRE HAEMOPHILUS/STREPTOCOCCUS PNEUMONIAE (HP) MIC PLATE Trek Diagnostic Systems, Ltd. | JWY |
| Sep 11, 2006 | K062022 | HAEMOPHILUS/STREPTOCOCCUS PNEUMONIAE (HP) MIC PLATE Trek Diagnostic Systems, Inc. | JWY |
| Aug 31, 2006 | K062190 | SENSITITRE HAEMOPHILUS / STREPTOCOCCUS PNEUMONIAE (HP) MIC PLATES Trek Diagnostic Systems, Inc. | JWY |
| Jul 21, 2006 | K061687 | MICROSCAN DRIED GRAM NEGATIVE MIC/COMBO PANELS Dade Behring, Inc. | JWY |
| Jul 18, 2006 | K061536 | MICROSCAN DRIED GRAM NEGATIVE MIC/COMBO PANELS Dade Behring, Inc. | JWY |
| May 16, 2006 | K060783 | SUSCEPTIBILITY TEST PLATE FOR VANCOMYCIN VRSA LIMITATION REMOVAL Trek Diagnostic Systems, Inc. | JWY |
| Apr 21, 2006 | K060621 | SUSCEPTIBILITY TEST PLATE FOR ERTAPENEM 0.002-16UG/ML FOR GRAM NEGATIVE. SUSCEPTIBILITY TEST PLATE FOR ERTAPENEM 0.015- Tds Holdings, Inc. | JWY |
| Oct 13, 2005 | K052366 | ETEST TIGECYCLINE GRAM POSITIVE AND GRAM NEGATIVE AEROBIC BACTERIA, STREPTOCOCCUS SPP. AND ANAEROBIC BACTERIA Ab Biodisk, SE | JWY |
| Sep 21, 2005 | K052091 | SENSITIRE SUSCEPTIBILITY PLATES- ADDITIONAL ANTIMICROBICS Trek Diagnostic Systems, Inc. | JWY |
| Jun 23, 2005 | K051202 | DRIED GRAM-POSITIVE MIC/COMBO PANELS Dade Behring, Inc. | JWY |
| Feb 14, 2005 | K043589 | MICROSCAN DRIED GRAM-POSITIVE MIC/COMBO PANELS - ERTAPENEM Dade Microscan, Inc. | JWY |
| Dec 13, 2004 | K042392 | DAPTOMYCIN Ab Biodisk, SE | JWY |
| Nov 19, 2004 | K042390 | ETEST FOR GEMIFLOXACIN Ab Biodisk, SE | JWY |
| Oct 7, 2004 | K042331 | PASCO MIC AND MIC/ID PANELS Pasco Laboratories, Inc. | JWY |
| Aug 3, 2004 | K041776 | PASCO MIC AND MIC/ID PANELS Pasco Laboratories, Inc. | JWY |
| Jul 27, 2004 | K041534 | SENSITITRE HAEMOPHILUS/STREPTOCOCCUS PNEUMONIAE (HP) MIC SUSCEPTIBILITY PLATE AND SUSCEPTIBILITY TEST PANEL Trek Diagnostic Systems, Ltd. | JWY |
| Jun 7, 2004 | K041214 | PASCO MIC AND MIC/ID PANELS Pasco Laboratories, Inc. | JWY |
| Apr 26, 2004 | K040846 | SENSITITRE HAEMOPHILUS/STREPTOCOCCUS PNEUMONIAE (HP) MIC PLATES Trek Diagnostic Systems, Inc. | JWY |
| Apr 7, 2004 | K040619 | SENSITITRE HAEMOPHILUS/STREPTOCOCCUS PNEUMONIAE (HP) MIC PLATES Trek Diagnostic Systems, Inc. | JWY |
| Feb 10, 2004 | K032706 | MICROSCAN DRIED GRAM-NEGATIVE MIC/COMBO PANELS WITH ERTAPENEM (0.002-32 MCG/ML Dade Behring, Inc. | JWY |
| Feb 3, 2004 | K033522 | SENSITITRE 18-24 HOURS SUSCEPTIBILITY PLATES Trek Diagnostic Systems, Inc. | JWY |
| Nov 18, 2003 | K033119 | PASCO MIC AND MIC/ID PANELS Pasco Laboratories, Inc. | JWY |
| Sep 15, 2003 | K032518 | PASCO MIC AND MIC/ID PANELS, GEMIFLOXACIN (STREP) Bd Diagnostic Systems | JWY |
| Aug 29, 2003 | K032382 | SENSITITRE HAEMOPHILUS/STREPTOCOCCUS PNEUMONIAE (HP) MIC PLATES Trek Diagnostic Systems, Inc. | JWY |
| Aug 19, 2003 | K032259 | PASCO MIC AND MIC/ID PANELS Bd Diagnostic Systems | JWY |
| Jul 30, 2003 | K031727 | PASCO MIC AND MIC/ID PANELS, GEMIFLOXACIN Pasco Laboratories, Inc. | JWY |
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