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JWY

441 FDA 510(k) clearances · Product code

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RecordFirmDate
SENSITITRE HAEMOPHILUS/STREPTOCOCCUS PNEUMONIAE(HP) SUSCEPTIBILITY PLATES (K140985)Thermo Fisher Scientific2014-06-10
SENSITITRE 18-24 HOUR MIC SUCEPTIBILITY SYSTEM (K133773)Thermo Fisher Scientific2014-02-27
ETEST CEFTAROLINE (K121002)bioMerieux, Inc.2012-10-12
VIZION (K112276)Trek Diagnostic Systems2011-11-16
SENSITITRE 18-24 HR SUSCEPTIBILITY PLATES (K111615)Trek Diagnostic Systems2011-11-08
SENSITITRE (R) HP MIC SUSCEPTIBILITY PLATE WITH CEFAROLINE (0.004-8UG/ML) AND THE SENSITITRE (R) 18-24 HOUR MIC SUSCE... (K111429)Trek Diagnostic Systems, Ltd.2011-08-18
ETEST TELAVANCIN IN 0.002-32 UG/ML AND 0.016-256 UG/ML (K102535)Biomerieux S.A.2011-05-16
ETEST TOBRAMYCIN 0.016-256 UG/ML AND 0.064-1024 UG/ML (K102668)BIOMERIEUX2010-11-17
ETEST MOXIFLOXACIN 0.002-32 UG/ML (K093604)Ab Biomerieux2010-08-25
SENSITIVE HAEMOPHILUS INFLUENZAE, STREPTOCOCCUS PNEUMONIA, (HP) MIC SUSCEPTIBILITY PLATES (K093741)Trek Diagnostic Systems, Ltd.2010-02-25
SENSITITRE 18-24HR SUSCEPTIBILITY PLATES (K093865)Trek Diagnostic Systems, Inc.2010-02-17
SENSITITRE 18-24 HOUR SUSCEPTIBILITY PLATES (K092445)Trek Diagnostic Systems, Ltd.2009-12-16
SENSITITRE 18-24 HOUR SUSECEPTIBILITY PLATES (K083606)Trek Diagnostic Systems, Inc.2009-03-24
SENSITITRE VIZION (K081520)Trek Diagnostic Systems, Inc.2008-10-24
MICROSCAN DRIED GRAM-POSITIVE MIC/COMBO PANELS NEW ANTIMICROBIAL TEST - INDUCIBLE CLINDAMYCIN (K081182)Siemens2008-08-08
ETEST DORIPENEM - ANTIMICROBIAL SUSCEPTIBILITY TEST - MIC AT 0.002-32 UG/ML (K081325)Ab Biodisk2008-07-24
SENSITITRE 18 - 24 HOUR SUSCEPTIBILITY PLATE (K073653)Trek Diagnostic Systems, Inc.2008-03-20
SENSITITRE 18-24 SUSCEPTIBILITY PLATE (K073558)Trek Diagnostic Systems, Inc.2008-03-13
SENSITITRE 18-24 HOUR SUSCEPTIBILITY PLATES (K073424)Trek Diagnostic Systems, Inc.2008-01-22
SENSITITRE HAEMOPHILUS/STREPTOCOCCUS PNEUMONIAE (HP) MIC AND SUSCEPTIBILITY PLATES (K062841)Trek Diagnostic Systems, Inc.2006-12-20
MODIFICATION TO SENSITITRE HAEMOPHILUS/STREPTOCOCCUS PNEUMONIAE (HP) MIC PLATE (K062839)Trek Diagnostic Systems, Inc.2006-11-09
SENSITITRE HAEMOPHILUS/STREPTOCOCCUS PNEUMONIAE (HP) MIC PLATE (K062816)Trek Diagnostic Systems, Inc.2006-11-01
SENSITITRE HAEMOPHILUS/STREPTOCOCCUS PNEUMONIAE (HP) MIC PLATE (K062783)Trek Diagnostic Systems, Inc.2006-10-26
SENSITITRE HAEMOPHILUS/STREPTOCOCCUS PNEUMONIAE (HP) MIC PLATE (K062722)Trek Diagnostic Systems, Inc.2006-10-20
SENSITITRE HAEMOPHILUS/STREPTOCOCCUS PNEUMONIAE (HP) MIC PLATE (K062681)Trek Diagnostic Systems, Ltd.2006-10-13
HAEMOPHILUS/STREPTOCOCCUS PNEUMONIAE (HP) MIC PLATE (K062022)Trek Diagnostic Systems, Inc.2006-09-11
SENSITITRE HAEMOPHILUS / STREPTOCOCCUS PNEUMONIAE (HP) MIC PLATES (K062190)Trek Diagnostic Systems, Inc.2006-08-31
MICROSCAN DRIED GRAM NEGATIVE MIC/COMBO PANELS (K061687)Dade Behring, Inc.2006-07-21
MICROSCAN DRIED GRAM NEGATIVE MIC/COMBO PANELS (K061536)Dade Behring, Inc.2006-07-18
SUSCEPTIBILITY TEST PLATE FOR VANCOMYCIN VRSA LIMITATION REMOVAL (K060783)Trek Diagnostic Systems, Inc.2006-05-16
SUSCEPTIBILITY TEST PLATE FOR ERTAPENEM 0.002-16UG/ML FOR GRAM NEGATIVE. SUSCEPTIBILITY TEST PLATE FOR ERTAPENEM 0.015- (K060621)Tds Holdings, Inc.2006-04-21
ETEST TIGECYCLINE GRAM POSITIVE AND GRAM NEGATIVE AEROBIC BACTERIA, STREPTOCOCCUS SPP. AND ANAEROBIC BACTERIA (K052366)Ab Biodisk2005-10-13
SENSITIRE SUSCEPTIBILITY PLATES- ADDITIONAL ANTIMICROBICS (K052091)Trek Diagnostic Systems, Inc.2005-09-21
DRIED GRAM-POSITIVE MIC/COMBO PANELS (K051202)Dade Behring, Inc.2005-06-23
MICROSCAN DRIED GRAM-POSITIVE MIC/COMBO PANELS - ERTAPENEM (K043589)Dade Microscan, Inc.2005-02-14
DAPTOMYCIN (K042392)Ab Biodisk2004-12-13
ETEST FOR GEMIFLOXACIN (K042390)Ab Biodisk2004-11-19
PASCO MIC AND MIC/ID PANELS (K042331)Pasco Laboratories, Inc.2004-10-07
PASCO MIC AND MIC/ID PANELS (K041776)Pasco Laboratories, Inc.2004-08-03
SENSITITRE HAEMOPHILUS/STREPTOCOCCUS PNEUMONIAE (HP) MIC SUSCEPTIBILITY PLATE AND SUSCEPTIBILITY TEST PANEL (K041534)Trek Diagnostic Systems, Ltd.2004-07-27
PASCO MIC AND MIC/ID PANELS (K041214)Pasco Laboratories, Inc.2004-06-07
SENSITITRE HAEMOPHILUS/STREPTOCOCCUS PNEUMONIAE (HP) MIC PLATES (K040846)Trek Diagnostic Systems, Inc.2004-04-26
SENSITITRE HAEMOPHILUS/STREPTOCOCCUS PNEUMONIAE (HP) MIC PLATES (K040619)Trek Diagnostic Systems, Inc.2004-04-07
MICROSCAN DRIED GRAM-NEGATIVE MIC/COMBO PANELS WITH ERTAPENEM (0.002-32 MCG/ML (K032706)Dade Behring, Inc.2004-02-10
SENSITITRE 18-24 HOURS SUSCEPTIBILITY PLATES (K033522)Trek Diagnostic Systems, Inc.2004-02-03
PASCO MIC AND MIC/ID PANELS (K033119)Pasco Laboratories, Inc.2003-11-18
PASCO MIC AND MIC/ID PANELS, GEMIFLOXACIN (STREP) (K032518)Bd Diagnostic Systems2003-09-15
SENSITITRE HAEMOPHILUS/STREPTOCOCCUS PNEUMONIAE (HP) MIC PLATES (K032382)Trek Diagnostic Systems, Inc.2003-08-29
PASCO MIC AND MIC/ID PANELS (K032259)Bd Diagnostic Systems2003-08-19
PASCO MIC AND MIC/ID PANELS, GEMIFLOXACIN (K031727)Pasco Laboratories, Inc.2003-07-30
SENSITITRE 18-24 HOUR SUSCEPTIBILITY PLATE (K031545)Trek Diagnostic Systems, Inc.2003-07-16
PASCO MIC AND MIC/ID PANELS (K031205)Pasco Laboratories, Inc.2003-06-13
PASCO MIC AND MIC/ID PANELS (ERTAPENEM) (K031103)Pasco Laboratories, Inc.2003-06-12
PASCO MIC AND MIC/ID PANELS (K030933)Pasco Laboratories, Inc.2003-05-01
MICROSCAN SYNERGIES PLUS (K023202)Dade Microscan, Inc.2002-10-23
SENSITITRE 18-24 HOURS SUSCEPTIBILITY PLATES (K022656)Trek Diagnostic Systems, Inc.2002-10-08
SENSITITRE 18-24 HOURS SUSCEPTIBILITY PLATES (K022775)Trek Diagnostic Systems, Inc.2002-09-25
SENSITITRE HAEMOPHILUS/STREPTOCOCCUS PNEUMONIAE (HP) MIC PLATE (K021997)Trek Diagnostic Systems, Inc.2002-09-25
SENSITITRE HAEMOPHILUS/STREPTOCOCCUS PNEUMONIAE (HP) MIC PLATE (K021627)Trek Diagnostic Systems, Inc.2002-06-20
MICROSCAN MICROSTREP PLUS PANEL NEW ANTICROBIAL-CLARITHROMYCIN (K021181)Dade Microscan, Inc.2002-06-17
MICROSCAN MICROSTREP PLUS PANEL - CHLORAMPHENICOL (K021018)Dade Microscan, Inc.2002-06-11
ETEST CEFDITOREN FOR S. PNEUMONIAE AND H. INFLUENZAE (K021445)Ab Biodisk2002-06-06
MICROSTREP PLUS PANEL, AZITHROMYCIN (K021169)Dade Microscan, Inc.2002-06-06
MICROSCAN MICROSTREP PLUS PANEL NEW ANTIMICROBIAL- CEFTRIAXONE (K021110)Dade Microscan, Inc.2002-06-06
MICROSCAN MICROSTREP PLUS PANEL NEW ANTIMICROBIAL-CEFEPIME (K021188)Dade Microscan, Inc.2002-06-06
MICROSCAN MICROSTREP PLUS PANEL-MEROPENEM (K020938)Dade Microscan, Inc.2002-06-03
CEFOTAXIME (K020859)Trek Diagnostic Systems, Inc.2002-05-15
HAEMOPHILUS/STREPTOCOCCUS PNEUMONIAE (K021339)Trek Diagnostic Systems, Inc.2002-05-09
GATIFLOXIN (K020762)Trek Diagnostic Systems, Inc.2002-05-09
MICROSCAN MICROSTEP PLUS PANEL NEW ANTIMICROBIAL - CEFUROXIME (K020820)Dade Behring, Inc.2002-05-09
MICROSCAN MICROSTEP PLUS PANEL NEW ANTIMICROBIAL - VANCOMYCIN (K020822)Dade Behring, Inc.2002-05-08
MICROSCAN MICROSTREP PLUS PANEL-AMOXICILLIN/CLAVULANIC ACID (K020937)Dade Microscan, Inc.2002-05-06
MICROSTREP PLUS PANEL WITH AMPICILLIN (K021037)Dade Behring, Inc.2002-05-06
MICROSCAN MICROSTREP PLUS PANEL NEW ANTIMICROBIAL - CEFACLOR (K020691)Dade Microscan, Inc.2002-04-30
MICROSCAN MICROSTREP PLUS PANEL NEW ANTIMICROBIAL - TRIMETHOPRIM/SULFAMETHOXAZOLE (K020686)Dade Microscan, Inc.2002-04-30
ETEST ERTAPENEM (K020748)Ab Biodisk2002-04-29
MICROSCAN MICROSTREP PLUS PANEL WITH LEVOFLOXACIN (K020556)Dade Microscan, Inc.2002-04-26
SENSITITRE HEAMOPHILUS/STREPTOCOCCUS PNEUMONIAE (HP) MIC PLATE (K014259)Trek Diagnostic Systems, Inc.2002-03-26
DRIED GRAM NEGATIVE MIC/COMBO PANELS (K020037)Dade Microscan, Inc.2002-03-22
PASCO MIC AND MIC/ID PANELS (K020331)Pasco Laboratories, Inc.2002-03-20
DRIED GRAM-POSITIVE MIC/COMBO PANELS WITH PENICILLIN (K020162)Dade Behring, Inc.2002-03-14
SENSITITRE HAEMOPHILUS/STREPTOCOCCUS PNEUMONIAE (HP) MIC PLATE (K014258)Trek Diagnostic Systems, Inc.2002-02-19
SENSITITRE HAEMOPHILUS/STREPTOCOCCUS PNEUMONIAE (HP) MIC SUSCEPTIBILITY PLATES (K013925)Trek Diagnostic Systems, Inc.2001-12-21
SENSITITRE HAEMOPHILUS/STREPTOCOCCUS PNEUMONIAE (HP) MIC SUSCEPTIBILITY PLATE (K013580)Trek Diagnostic Systems, Inc.2001-12-12
MICROSCAN DRIED GRAM NEGATIVE OVERNIGHT MIC/COMBO PANELS (K013423)Dade Microscan, Inc.2001-12-12
SENSITITRE HAEMOPHILUS/STREPTOCOCCUS PNEUMONIAE (HP) MIC PLATE (K013075)Trek Diagnostic Systems, Inc.2001-11-26
SENSITITRE HAEMOPHILUS/STREPTOCOCCUS PNEUMONIAE (HP) MIC PLATE (K012921)Trek Diagnostic Systems, Inc.2001-11-02
HEAMOPHILUS/STREPTOCOCCUS PNEUMONIAE (K012895)Trek Diagnostic Systems, Inc.2001-10-30
SENSITITRE HAEMOPHILUS/STREPTOCOCCUS PNEUMONIAE (HP) MIC PLATE (K012565)Trek Diagnostic Systems, Inc.2001-09-12
HAEMOPHILUS/STREPTOCOCCUS PNEUMONIAE (HP) MIC PLATE (K012151)Trek Diagnostic Systems, Inc.2001-08-29
SENSITITRE 18 - 24 HOURS SUSCEPTIBILITY PLATES (K011803)Trek Diagnostic Systems, Inc.2001-08-15
ETEST MEROPENEM (K010363)Ab Biodisk2001-04-09
SUSCEPTIBILITY TEST PANEL (K004045)Trek Diagnostic Systems, Inc.2001-03-06
SENSITITRE SUSCEPTIBILITY PLATES-ADDITIONAL ANTIMICROBICS (K003868)Trek Diagnostic Systems, Inc.2001-02-27
SENSITITRE SUSCEPTIBILITY PLATES-ADDITIONAL ANTIMICROBICS (K003834)Trek Diagnostic Systems, Inc.2001-02-23
PASCO MIC AND MIC/ID PANELS (K001953)Pasco Laboratories, Inc.2000-08-10
MODIFICATION TO PASCO MIC AND MIC/ID PANELS (K001887)Pasco Laboratories, Inc.2000-08-09
ETEST ESBL CT/CTL STRIP; ETEST ESBL TZ/TZL STRIP (K001547)Ab Biodisk2000-08-07
SENSITITRE 18-24 HOURS SUSCEPTIBILITY PLATES (QUINUPRISTIN/DALFOPRISTIN) (K001558)Trek Diagnostic Systems, Inc.2000-07-24
PASCO MIC AND MIC/ID PANELS (K001612)Pasco Laboratories, Inc.2000-07-18
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