FDA Product Code
FDA Product Code JWY — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Microbiology
- 21 CFR Citation
- 866.1640
510(k) Clearances — 441 records · page 2 of 5
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K140985 | SENSITITRE HAEMOPHILUS/STREPTOCOCCUS PNEUMONIAE(HP) SUSCEPTIBILITY PLATES | Thermo Fisher Scientific | 2014-06-10 | Traditional | PDF ↗ |
| K133773 | SENSITITRE 18-24 HOUR MIC SUCEPTIBILITY SYSTEM | Thermo Fisher Scientific | 2014-02-27 | Traditional | PDF ↗ |
| K121002 | ETEST CEFTAROLINE | bioMerieux, Inc. | 2012-10-12 | Traditional | PDF ↗ |
| K112276 | VIZION | Trek Diagnostic Systems | 2011-11-16 | Traditional | PDF ↗ |
| K111615 | SENSITITRE 18-24 HR SUSCEPTIBILITY PLATES | Trek Diagnostic Systems | 2011-11-08 | Traditional | PDF ↗ |
| 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. | 2011-08-18 | Traditional | PDF ↗ |
| K102535 | ETEST TELAVANCIN IN 0.002-32 UG/ML AND 0.016-256 UG/ML | Biomerieux S.A. | 2011-05-16 | Traditional | PDF ↗ |
| K102668 | ETEST TOBRAMYCIN 0.016-256 UG/ML AND 0.064-1024 UG/ML | BIOMERIEUX | 2010-11-17 | Traditional | PDF ↗ |
| K093604 | ETEST MOXIFLOXACIN 0.002-32 UG/ML | Ab Biomerieux | 2010-08-25 | Traditional | PDF ↗ |
| K093741 | SENSITIVE HAEMOPHILUS INFLUENZAE, STREPTOCOCCUS PNEUMONIA, (HP) MIC SUSCEPTIBILITY PLATES | Trek Diagnostic Systems, Ltd. | 2010-02-25 | Traditional | PDF ↗ |
| K093865 | SENSITITRE 18-24HR SUSCEPTIBILITY PLATES | Trek Diagnostic Systems, Inc. | 2010-02-17 | Traditional | PDF ↗ |
| K092445 | SENSITITRE 18-24 HOUR SUSCEPTIBILITY PLATES | Trek Diagnostic Systems, Ltd. | 2009-12-16 | Traditional | PDF ↗ |
| K083606 | SENSITITRE 18-24 HOUR SUSECEPTIBILITY PLATES | Trek Diagnostic Systems, Inc. | 2009-03-24 | Traditional | PDF ↗ |
| K081520 | SENSITITRE VIZION | Trek Diagnostic Systems, Inc. | 2008-10-24 | Special | PDF ↗ |
| K081182 | MICROSCAN DRIED GRAM-POSITIVE MIC/COMBO PANELS NEW ANTIMICROBIAL TEST - INDUCIBLE CLINDAMYCIN | Siemens | 2008-08-08 | Traditional | PDF ↗ |
| K081325 | ETEST DORIPENEM - ANTIMICROBIAL SUSCEPTIBILITY TEST - MIC AT 0.002-32 UG/ML | Ab Biodisk | 2008-07-24 | Traditional | PDF ↗ |
| K073653 | SENSITITRE 18 - 24 HOUR SUSCEPTIBILITY PLATE | Trek Diagnostic Systems, Inc. | 2008-03-20 | Traditional | PDF ↗ |
| K073558 | SENSITITRE 18-24 SUSCEPTIBILITY PLATE | Trek Diagnostic Systems, Inc. | 2008-03-13 | Traditional | PDF ↗ |
| K073424 | SENSITITRE 18-24 HOUR SUSCEPTIBILITY PLATES | Trek Diagnostic Systems, Inc. | 2008-01-22 | Traditional | PDF ↗ |
| K062841 | SENSITITRE HAEMOPHILUS/STREPTOCOCCUS PNEUMONIAE (HP) MIC AND SUSCEPTIBILITY PLATES | Trek Diagnostic Systems, Inc. | 2006-12-20 | Traditional | PDF ↗ |
| K062839 | MODIFICATION TO SENSITITRE HAEMOPHILUS/STREPTOCOCCUS PNEUMONIAE (HP) MIC PLATE | Trek Diagnostic Systems, Inc. | 2006-11-09 | Traditional | PDF ↗ |
| K062816 | SENSITITRE HAEMOPHILUS/STREPTOCOCCUS PNEUMONIAE (HP) MIC PLATE | Trek Diagnostic Systems, Inc. | 2006-11-01 | Traditional | PDF ↗ |
| K062783 | SENSITITRE HAEMOPHILUS/STREPTOCOCCUS PNEUMONIAE (HP) MIC PLATE | Trek Diagnostic Systems, Inc. | 2006-10-26 | Traditional | PDF ↗ |
| K062722 | SENSITITRE HAEMOPHILUS/STREPTOCOCCUS PNEUMONIAE (HP) MIC PLATE | Trek Diagnostic Systems, Inc. | 2006-10-20 | Traditional | PDF ↗ |
| K062681 | SENSITITRE HAEMOPHILUS/STREPTOCOCCUS PNEUMONIAE (HP) MIC PLATE | Trek Diagnostic Systems, Ltd. | 2006-10-13 | Traditional | PDF ↗ |
| K062022 | HAEMOPHILUS/STREPTOCOCCUS PNEUMONIAE (HP) MIC PLATE | Trek Diagnostic Systems, Inc. | 2006-09-11 | Traditional | PDF ↗ |
| K062190 | SENSITITRE HAEMOPHILUS / STREPTOCOCCUS PNEUMONIAE (HP) MIC PLATES | Trek Diagnostic Systems, Inc. | 2006-08-31 | Traditional | PDF ↗ |
| K061687 | MICROSCAN DRIED GRAM NEGATIVE MIC/COMBO PANELS | Dade Behring, Inc. | 2006-07-21 | Traditional | PDF ↗ |
| K061536 | MICROSCAN DRIED GRAM NEGATIVE MIC/COMBO PANELS | Dade Behring, Inc. | 2006-07-18 | Traditional | PDF ↗ |
| K060783 | SUSCEPTIBILITY TEST PLATE FOR VANCOMYCIN VRSA LIMITATION REMOVAL | Trek Diagnostic Systems, Inc. | 2006-05-16 | Traditional | PDF ↗ |
| K060621 | SUSCEPTIBILITY TEST PLATE FOR ERTAPENEM 0.002-16UG/ML FOR GRAM NEGATIVE. SUSCEPTIBILITY TEST PLATE FOR ERTAPENEM 0.015- | Tds Holdings, Inc. | 2006-04-21 | Traditional | PDF ↗ |
| K052366 | ETEST TIGECYCLINE GRAM POSITIVE AND GRAM NEGATIVE AEROBIC BACTERIA, STREPTOCOCCUS SPP. AND ANAEROBIC BACTERIA | Ab Biodisk | 2005-10-13 | Traditional | PDF ↗ |
| K052091 | SENSITIRE SUSCEPTIBILITY PLATES- ADDITIONAL ANTIMICROBICS | Trek Diagnostic Systems, Inc. | 2005-09-21 | Traditional | PDF ↗ |
| K051202 | DRIED GRAM-POSITIVE MIC/COMBO PANELS | Dade Behring, Inc. | 2005-06-23 | Traditional | PDF ↗ |
| K043589 | MICROSCAN DRIED GRAM-POSITIVE MIC/COMBO PANELS - ERTAPENEM | Dade Microscan, Inc. | 2005-02-14 | Traditional | PDF ↗ |
| K042392 | DAPTOMYCIN | Ab Biodisk | 2004-12-13 | Traditional | PDF ↗ |
| K042390 | ETEST FOR GEMIFLOXACIN | Ab Biodisk | 2004-11-19 | Traditional | PDF ↗ |
| K042331 | PASCO MIC AND MIC/ID PANELS | Pasco Laboratories, Inc. | 2004-10-07 | Traditional | PDF ↗ |
| K041776 | PASCO MIC AND MIC/ID PANELS | Pasco Laboratories, Inc. | 2004-08-03 | Traditional | PDF ↗ |
| K041534 | SENSITITRE HAEMOPHILUS/STREPTOCOCCUS PNEUMONIAE (HP) MIC SUSCEPTIBILITY PLATE AND SUSCEPTIBILITY TEST PANEL | Trek Diagnostic Systems, Ltd. | 2004-07-27 | Traditional | PDF ↗ |
| K041214 | PASCO MIC AND MIC/ID PANELS | Pasco Laboratories, Inc. | 2004-06-07 | Traditional | PDF ↗ |
| K040846 | SENSITITRE HAEMOPHILUS/STREPTOCOCCUS PNEUMONIAE (HP) MIC PLATES | Trek Diagnostic Systems, Inc. | 2004-04-26 | Traditional | PDF ↗ |
| K040619 | SENSITITRE HAEMOPHILUS/STREPTOCOCCUS PNEUMONIAE (HP) MIC PLATES | Trek Diagnostic Systems, Inc. | 2004-04-07 | Traditional | PDF ↗ |
| K032706 | MICROSCAN DRIED GRAM-NEGATIVE MIC/COMBO PANELS WITH ERTAPENEM (0.002-32 MCG/ML | Dade Behring, Inc. | 2004-02-10 | Traditional | PDF ↗ |
| K033522 | SENSITITRE 18-24 HOURS SUSCEPTIBILITY PLATES | Trek Diagnostic Systems, Inc. | 2004-02-03 | Traditional | PDF ↗ |
| K033119 | PASCO MIC AND MIC/ID PANELS | Pasco Laboratories, Inc. | 2003-11-18 | Traditional | PDF ↗ |
| K032518 | PASCO MIC AND MIC/ID PANELS, GEMIFLOXACIN (STREP) | Bd Diagnostic Systems | 2003-09-15 | Traditional | PDF ↗ |
| K032382 | SENSITITRE HAEMOPHILUS/STREPTOCOCCUS PNEUMONIAE (HP) MIC PLATES | Trek Diagnostic Systems, Inc. | 2003-08-29 | Traditional | PDF ↗ |
| K032259 | PASCO MIC AND MIC/ID PANELS | Bd Diagnostic Systems | 2003-08-19 | Traditional | PDF ↗ |
| K031727 | PASCO MIC AND MIC/ID PANELS, GEMIFLOXACIN | Pasco Laboratories, Inc. | 2003-07-30 | Traditional | PDF ↗ |
| K031545 | SENSITITRE 18-24 HOUR SUSCEPTIBILITY PLATE | Trek Diagnostic Systems, Inc. | 2003-07-16 | Traditional | PDF ↗ |
| K031205 | PASCO MIC AND MIC/ID PANELS | Pasco Laboratories, Inc. | 2003-06-13 | Traditional | PDF ↗ |
| K031103 | PASCO MIC AND MIC/ID PANELS (ERTAPENEM) | Pasco Laboratories, Inc. | 2003-06-12 | Traditional | PDF ↗ |
| K030933 | PASCO MIC AND MIC/ID PANELS | Pasco Laboratories, Inc. | 2003-05-01 | Traditional | PDF ↗ |
| K023202 | MICROSCAN SYNERGIES PLUS | Dade Microscan, Inc. | 2002-10-23 | Special | PDF ↗ |
| K022656 | SENSITITRE 18-24 HOURS SUSCEPTIBILITY PLATES | Trek Diagnostic Systems, Inc. | 2002-10-08 | Traditional | PDF ↗ |
| K021997 | SENSITITRE HAEMOPHILUS/STREPTOCOCCUS PNEUMONIAE (HP) MIC PLATE | Trek Diagnostic Systems, Inc. | 2002-09-25 | Traditional | PDF ↗ |
| K022775 | SENSITITRE 18-24 HOURS SUSCEPTIBILITY PLATES | Trek Diagnostic Systems, Inc. | 2002-09-25 | Traditional | PDF ↗ |
| K021627 | SENSITITRE HAEMOPHILUS/STREPTOCOCCUS PNEUMONIAE (HP) MIC PLATE | Trek Diagnostic Systems, Inc. | 2002-06-20 | Traditional | PDF ↗ |
| K021181 | MICROSCAN MICROSTREP PLUS PANEL NEW ANTICROBIAL-CLARITHROMYCIN | Dade Microscan, Inc. | 2002-06-17 | Traditional | PDF ↗ |
| K021018 | MICROSCAN MICROSTREP PLUS PANEL - CHLORAMPHENICOL | Dade Microscan, Inc. | 2002-06-11 | Traditional | PDF ↗ |
| K021445 | ETEST CEFDITOREN FOR S. PNEUMONIAE AND H. INFLUENZAE | Ab Biodisk | 2002-06-06 | Traditional | PDF ↗ |
| K021188 | MICROSCAN MICROSTREP PLUS PANEL NEW ANTIMICROBIAL-CEFEPIME | Dade Microscan, Inc. | 2002-06-06 | Traditional | PDF ↗ |
| K021110 | MICROSCAN MICROSTREP PLUS PANEL NEW ANTIMICROBIAL- CEFTRIAXONE | Dade Microscan, Inc. | 2002-06-06 | Traditional | PDF ↗ |
| K021169 | MICROSTREP PLUS PANEL, AZITHROMYCIN | Dade Microscan, Inc. | 2002-06-06 | Traditional | PDF ↗ |
| K020938 | MICROSCAN MICROSTREP PLUS PANEL-MEROPENEM | Dade Microscan, Inc. | 2002-06-03 | Traditional | PDF ↗ |
| K020859 | CEFOTAXIME | Trek Diagnostic Systems, Inc. | 2002-05-15 | Traditional | PDF ↗ |
| K021339 | HAEMOPHILUS/STREPTOCOCCUS PNEUMONIAE | Trek Diagnostic Systems, Inc. | 2002-05-09 | Traditional | PDF ↗ |
| K020820 | MICROSCAN MICROSTEP PLUS PANEL NEW ANTIMICROBIAL - CEFUROXIME | Dade Behring, Inc. | 2002-05-09 | Traditional | PDF ↗ |
| K020762 | GATIFLOXIN | Trek Diagnostic Systems, Inc. | 2002-05-09 | Traditional | PDF ↗ |
| K020822 | MICROSCAN MICROSTEP PLUS PANEL NEW ANTIMICROBIAL - VANCOMYCIN | Dade Behring, Inc. | 2002-05-08 | Traditional | PDF ↗ |
| K021037 | MICROSTREP PLUS PANEL WITH AMPICILLIN | Dade Behring, Inc. | 2002-05-06 | Traditional | PDF ↗ |
| K020937 | MICROSCAN MICROSTREP PLUS PANEL-AMOXICILLIN/CLAVULANIC ACID | Dade Microscan, Inc. | 2002-05-06 | Traditional | PDF ↗ |
| K020686 | MICROSCAN MICROSTREP PLUS PANEL NEW ANTIMICROBIAL - TRIMETHOPRIM/SULFAMETHOXAZOLE | Dade Microscan, Inc. | 2002-04-30 | Traditional | PDF ↗ |
| K020691 | MICROSCAN MICROSTREP PLUS PANEL NEW ANTIMICROBIAL - CEFACLOR | Dade Microscan, Inc. | 2002-04-30 | Traditional | PDF ↗ |
| K020748 | ETEST ERTAPENEM | Ab Biodisk | 2002-04-29 | Traditional | PDF ↗ |
| K020556 | MICROSCAN MICROSTREP PLUS PANEL WITH LEVOFLOXACIN | Dade Microscan, Inc. | 2002-04-26 | Traditional | PDF ↗ |
| K014259 | SENSITITRE HEAMOPHILUS/STREPTOCOCCUS PNEUMONIAE (HP) MIC PLATE | Trek Diagnostic Systems, Inc. | 2002-03-26 | Traditional | PDF ↗ |
| K020037 | DRIED GRAM NEGATIVE MIC/COMBO PANELS | Dade Microscan, Inc. | 2002-03-22 | Traditional | PDF ↗ |
| K020331 | PASCO MIC AND MIC/ID PANELS | Pasco Laboratories, Inc. | 2002-03-20 | Traditional | PDF ↗ |
| K020162 | DRIED GRAM-POSITIVE MIC/COMBO PANELS WITH PENICILLIN | Dade Behring, Inc. | 2002-03-14 | Traditional | PDF ↗ |
| K014258 | SENSITITRE HAEMOPHILUS/STREPTOCOCCUS PNEUMONIAE (HP) MIC PLATE | Trek Diagnostic Systems, Inc. | 2002-02-19 | Traditional | PDF ↗ |
| K013925 | SENSITITRE HAEMOPHILUS/STREPTOCOCCUS PNEUMONIAE (HP) MIC SUSCEPTIBILITY PLATES | Trek Diagnostic Systems, Inc. | 2001-12-21 | Traditional | PDF ↗ |
| K013580 | SENSITITRE HAEMOPHILUS/STREPTOCOCCUS PNEUMONIAE (HP) MIC SUSCEPTIBILITY PLATE | Trek Diagnostic Systems, Inc. | 2001-12-12 | Traditional | PDF ↗ |
| K013423 | MICROSCAN DRIED GRAM NEGATIVE OVERNIGHT MIC/COMBO PANELS | Dade Microscan, Inc. | 2001-12-12 | Traditional | PDF ↗ |
| K013075 | SENSITITRE HAEMOPHILUS/STREPTOCOCCUS PNEUMONIAE (HP) MIC PLATE | Trek Diagnostic Systems, Inc. | 2001-11-26 | Traditional | PDF ↗ |
| K012921 | SENSITITRE HAEMOPHILUS/STREPTOCOCCUS PNEUMONIAE (HP) MIC PLATE | Trek Diagnostic Systems, Inc. | 2001-11-02 | Traditional | PDF ↗ |
| K012895 | HEAMOPHILUS/STREPTOCOCCUS PNEUMONIAE | Trek Diagnostic Systems, Inc. | 2001-10-30 | Traditional | PDF ↗ |
| K012565 | SENSITITRE HAEMOPHILUS/STREPTOCOCCUS PNEUMONIAE (HP) MIC PLATE | Trek Diagnostic Systems, Inc. | 2001-09-12 | Traditional | PDF ↗ |
| K012151 | HAEMOPHILUS/STREPTOCOCCUS PNEUMONIAE (HP) MIC PLATE | Trek Diagnostic Systems, Inc. | 2001-08-29 | Traditional | PDF ↗ |
| K011803 | SENSITITRE 18 - 24 HOURS SUSCEPTIBILITY PLATES | Trek Diagnostic Systems, Inc. | 2001-08-15 | Traditional | PDF ↗ |
| K010363 | ETEST MEROPENEM | Ab Biodisk | 2001-04-09 | Traditional | PDF ↗ |
| K004045 | SUSCEPTIBILITY TEST PANEL | Trek Diagnostic Systems, Inc. | 2001-03-06 | Traditional | PDF ↗ |
| K003868 | SENSITITRE SUSCEPTIBILITY PLATES-ADDITIONAL ANTIMICROBICS | Trek Diagnostic Systems, Inc. | 2001-02-27 | Traditional | PDF ↗ |
| K003834 | SENSITITRE SUSCEPTIBILITY PLATES-ADDITIONAL ANTIMICROBICS | Trek Diagnostic Systems, Inc. | 2001-02-23 | Traditional | PDF ↗ |
| K001953 | PASCO MIC AND MIC/ID PANELS | Pasco Laboratories, Inc. | 2000-08-10 | Traditional | PDF ↗ |
| K001887 | MODIFICATION TO PASCO MIC AND MIC/ID PANELS | Pasco Laboratories, Inc. | 2000-08-09 | Traditional | PDF ↗ |
| K001547 | ETEST ESBL CT/CTL STRIP; ETEST ESBL TZ/TZL STRIP | Ab Biodisk | 2000-08-07 | Traditional | PDF ↗ |
| K001558 | SENSITITRE 18-24 HOURS SUSCEPTIBILITY PLATES (QUINUPRISTIN/DALFOPRISTIN) | Trek Diagnostic Systems, Inc. | 2000-07-24 | Traditional | PDF ↗ |
| K001612 | PASCO MIC AND MIC/ID PANELS | Pasco Laboratories, Inc. | 2000-07-18 | Traditional | PDF ↗ |
Product code JWY · Class II · Microbiology. Data: openFDA.