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 |