Submission Details
| 510(k) Number | K092736 FDA.gov |
| FDA Decision | Cleared 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 |
Cleared
Traditional
EUROIMMUN ANTI-M2-3E ELISA (IGG)
Sep 2010
Decision
363d
Days
Class 2
Risk
About This 510(k) Submission
K092736 is an FDA 510(k) clearance for the EUROIMMUN ANTI-M2-3E ELISA (IGG), 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 review panel. Regulated under 21 CFR 866.5090.
Device Classification
| Product Code | DBM — Antimitochondrial Antibody, Indirect Immunofluorescent, Antigen, Control |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 866.5090 |
Manufacturer
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