The following data is part of a premarket notification filed by Techlab Inc., Corporate Research Center with the FDA for Leuko Ez Vue.
| Device ID | K071712 |
| 510k Number | K071712 |
| Device Name: | LEUKO EZ VUE |
| Classification | Lactoferrin, Antigen, Antiserum, Control |
| Applicant | TECHLAB INC., CORPORATE RESEARCH CENTER 2001 KRAFT DR. Blacksburg, VA 24060 -6358 |
| Contact | Charles Pennington |
| Correspondent | Charles Pennington TECHLAB INC., CORPORATE RESEARCH CENTER 2001 KRAFT DR. Blacksburg, VA 24060 -6358 |
| Product Code | DEG |
| CFR Regulation Number | 866.5570 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2007-06-22 |
| Decision Date | 2007-12-04 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00857031002172 | K071712 | 000 |
| 00857031002530 | K071712 | 000 |
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
![]() LEUKO EZ VUE 85333006 4090404 Live/Registered |
TechLab, Inc. 2011-05-27 |