K091969 is an FDA 510(k) clearance for the EUROIMMUN ANTI-DESMOGLEIN 1 ELISA (IGG), EUROIMMUN ANTI-DESMOGLEIN 3 ELISA (IGG). This device is classified as a Autoantibodies, Skin (desmoglein 1 And Desmoglein 3) (Class II - Special Controls, product code NBO).
Submitted by Euroimmun Us, Inc. (Morristown, US). The FDA issued a Cleared decision on September 2, 2010, 428 days after receiving the submission on July 1, 2009.
This device falls under the Immunology FDA review panel. Regulated under 21 CFR 866.5660.
| 510(k) Number | K091969 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | July 01, 2009 |
| Decision Date | September 02, 2010 |
| Days to Decision | 428 days |
| Submission Type | Traditional |
| Review Panel | Immunology (IM) |
| Summary | Summary PDF |
| Product Code | NBO - Autoantibodies, Skin (desmoglein 1 And Desmoglein 3) |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 866.5660 |