K062708 is an FDA 510(k) clearance for the QUANTA LITE CELIAC DGP SCREEN. This device is classified as a Antibodies, Gliadin (Class II - Special Controls, product code MST).
Submitted by Inova Diagnostics, Inc. (San Diego, US). The FDA issued a Cleared decision on December 13, 2006, 93 days after receiving the submission on September 11, 2006.
This device falls under the Immunology FDA review panel. Regulated under 21 CFR 866.5750.
| 510(k) Number | K062708 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 11, 2006 |
| Decision Date | December 13, 2006 |
| Days to Decision | 93 days |
| Submission Type | Traditional |
| Review Panel | Immunology (IM) |
| Summary | Summary PDF |
| Product Code | MST — Antibodies, Gliadin |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 866.5750 |