K183313 is an FDA 510(k) clearance for the EUROIMMUN Anti-tissue Transglutaminase ELISA (IgA), EUROIMMUN Anti-tissue Transglutaminase ELISA (IgG). This device is classified as a Autoantibodies, Endomysial(tissue Transglutaminase) (Class II - Special Controls, product code MVM).
Submitted by Euroimmun Us, Inc. (Mountain Lakes, US). The FDA issued a Cleared decision on February 28, 2019, 91 days after receiving the submission on November 29, 2018.
This device falls under the Immunology FDA review panel. Regulated under 21 CFR 866.5660.
| 510(k) Number | K183313 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | November 29, 2018 |
| Decision Date | February 28, 2019 |
| Days to Decision | 91 days |
| Submission Type | Traditional |
| Review Panel | Immunology (IM) |
| Summary | Statement |
| Product Code | MVM - Autoantibodies, Endomysial(tissue Transglutaminase) |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 866.5660 |