K092736 is an FDA 510(k) clearance for the EUROIMMUN ANTI-M2-3E ELISA (IGG). This device is classified as a Antimitochondrial Antibody, Indirect Immunofluorescent, Antigen, Control (Class II - Special Controls, product code DBM).
Submitted by Euroimmun Us, Inc. (Morristown, US). The FDA issued a Cleared decision on September 2, 2010, 363 days after receiving the submission on September 4, 2009.
This device falls under the Immunology FDA review panel. Regulated under 21 CFR 866.5090.
| 510(k) Number | K092736 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 04, 2009 |
| Decision Date | September 02, 2010 |
| Days to Decision | 363 days |
| Submission Type | Traditional |
| Review Panel | Immunology (IM) |
| Summary | Summary PDF |
| Product Code | DBM - Antimitochondrial Antibody, Indirect Immunofluorescent, Antigen, Control |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 866.5090 |