K083381 is an FDA 510(k) clearance for the EUROIMMUN ANTI-DSDNA-NCX ELISA (IGG). This device is classified as a Anti-dna Antibody (enzyme-labeled), Antigen, Control (Class II - Special Controls, product code LRM).
Submitted by Euroimmun Us, Inc. (Morristown, US). The FDA issued a Cleared decision on April 15, 2009, 152 days after receiving the submission on November 14, 2008.
This device falls under the Immunology FDA review panel. Regulated under 21 CFR 866.5100.
| 510(k) Number | K083381 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | November 14, 2008 |
| Decision Date | April 15, 2009 |
| Days to Decision | 152 days |
| Submission Type | Traditional |
| Review Panel | Immunology (IM) |
| Summary | Statement |
| Product Code | LRM - Anti-dna Antibody (enzyme-labeled), Antigen, Control |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 866.5100 |