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 |