The following data is part of a premarket notification filed by Trek Diagnostic Systems with the FDA for Vizion.
| Device ID | K112276 |
| 510k Number | K112276 |
| Device Name: | VIZION |
| Classification | Manual Antimicrobial Susceptibility Test Systems |
| Applicant | TREK DIAGNOSTIC SYSTEMS 982 KEYNOTE CIRCLE Cleveland, OH 44131 |
| Contact | Cynthia C Knapp |
| Correspondent | Cynthia C Knapp TREK DIAGNOSTIC SYSTEMS 982 KEYNOTE CIRCLE Cleveland, OH 44131 |
| Product Code | JWY |
| CFR Regulation Number | 866.1640 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2011-08-09 |
| Decision Date | 2011-11-16 |
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
![]() VIZION 98529708 not registered Live/Pending |
SPORT MASKA INC. 2024-05-01 |
![]() VIZION 88593461 not registered Live/Pending |
YTY Industry Sdn Bhd 2019-08-26 |
![]() VIZION 88267315 not registered Live/Pending |
Raul Griffith 2019-01-18 |
![]() VIZION 88201403 not registered Dead/Abandoned |
HIGHLY FAVORED GROUP, INC. 2018-11-20 |
![]() VIZION 88079204 not registered Live/Pending |
CMS Payments Intelligence, Inc. 2018-08-15 |
![]() VIZION 87734650 not registered Dead/Abandoned |
Global Transportation Management Solutions, Inc. 2017-12-26 |
![]() VIZION 86772473 5233260 Live/Registered |
KONICA MINOLTA HEALTHCARE AMERICAS, INC. 2015-09-29 |
![]() VIZION 85910109 4443623 Live/Registered |
James Anthony Christian Haley 2013-04-20 |
![]() VIZION 85518273 4263545 Dead/Cancelled |
A.J. Antunes & Co. 2012-01-17 |
![]() VIZION 85457878 not registered Dead/Abandoned |
The Marvel Group, Inc. 2011-10-27 |
![]() VIZION 85356007 4136992 Dead/Cancelled |
Thor Tech, Inc. 2011-06-24 |
![]() VIZION 85016070 3912434 Live/Registered |
Palziv North America, Inc. 2010-04-16 |