VERSATREK
System, Blood Culturing
TREK DIAGNOSTIC SYSTEMS, INC.
The following data is part of a premarket notification filed by Trek Diagnostic Systems, Inc. with the FDA for Versatrek.
Pre-market Notification Details
| Device ID | K032306 |
| 510k Number | K032306 |
| Device Name: | VERSATREK |
| Classification | System, Blood Culturing |
| Applicant | TREK DIAGNOSTIC SYSTEMS, INC. 982 KEYNOTE CIRCLE SUITE 6 Cleveland, OH 44131 |
| Contact | Nadine M Sullivan |
| Correspondent | Nadine M Sullivan TREK DIAGNOSTIC SYSTEMS, INC. 982 KEYNOTE CIRCLE SUITE 6 Cleveland, OH 44131 |
| Product Code | MDB |
| CFR Regulation Number | 866.2560 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2003-07-25 |
| Decision Date | 2003-08-22 |
Trademark Results [VERSATREK]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 VERSATREK 76597210 3010252 Live/Registered |
TREK DIAGNOSTIC SYSTEMS LLC 2004-06-14 |
 VERSATREK 76428803 2866022 Live/Registered |
Trek Diagnostic Systems LLC 2002-07-01 |
© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.