The following data is part of a premarket notification filed by Techlab, Inc. with the FDA for Leuko-test.
Device ID | K951101 |
510k Number | K951101 |
Device Name: | LEUKO-TEST |
Classification | Lactoferrin, Antigen, Antiserum, Control |
Applicant | TECHLAB, INC. 1861 PRATT DR., STE. 1030 Blacksburg, VA 24060 -6364 |
Contact | David M Lyerly |
Correspondent | David M Lyerly TECHLAB, INC. 1861 PRATT DR., STE. 1030 Blacksburg, VA 24060 -6364 |
Product Code | DEG |
CFR Regulation Number | 866.5570 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1995-03-10 |
Decision Date | 1995-04-24 |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
LEUKO-TEST 75044964 2143895 Dead/Cancelled |
TechLab, Inc. 1996-01-18 |