K083053 is an FDA 510(k) clearance for the EUROIMMUN ANTI-GLIADIN (GAF-3X) ELISA (IGG). This device is classified as a Antibodies, Gliadin (Class II - Special Controls, product code MST).
Submitted by Euroimmun Us, Inc. (Morristown, US). The FDA issued a Cleared decision on August 7, 2009, 297 days after receiving the submission on October 14, 2008.
This device falls under the Immunology FDA review panel. Regulated under 21 CFR 866.5750.
| 510(k) Number | K083053 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | October 14, 2008 |
| Decision Date | August 07, 2009 |
| Days to Decision | 297 days |
| Submission Type | Traditional |
| Review Panel | Immunology (IM) |
| Summary | Statement |
| Product Code | MST — Antibodies, Gliadin |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 866.5750 |