K042071 is an FDA 510(k) clearance for the IBD-SCAN. This device is classified as a Lactoferrin, Antigen, Antiserum, Control (Class I - General Controls, product code DEG).
Submitted by Techlab, Inc. (Blacksburg, US). The FDA issued a Cleared decision on October 20, 2004, 79 days after receiving the submission on August 2, 2004.
This device falls under the Immunology FDA review panel. Regulated under 21 CFR 866.5570.
| 510(k) Number | K042071 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | August 02, 2004 |
| Decision Date | October 20, 2004 |
| Days to Decision | 79 days |
| Submission Type | Traditional |
| Review Panel | Immunology (IM) |
| Summary | Statement |
| Product Code | DEG — Lactoferrin, Antigen, Antiserum, Control |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 866.5570 |