The following data is part of a premarket notification filed by Techlab, Inc. with the FDA for Ibd-quik Chek.
Device ID | K030704 |
510k Number | K030704 |
Device Name: | IBD-QUIK CHEK |
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 | 2003-03-06 |
Decision Date | 2003-04-21 |
Summary: | summary |
Device Identifier | submissionNumber | Supplement |
---|---|---|
00857031002189 | K030704 | 000 |
00857031002585 | K030704 | 000 |
00857031002356 | K030704 | 000 |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
IBD-QUIK CHEK 76276404 2952144 Dead/Cancelled |
TechLab, Inc. 2001-06-25 |