The following data is part of a premarket notification filed by Euroimmun Us with the FDA for Euroimmun Euroline Profile Autoimmune Liver Disease 8ag (igg).
| Device ID | K113439 |
| 510k Number | K113439 |
| Device Name: | EUROIMMUN EUROLINE PROFILE AUTOIMMUNE LIVER DISEASE 8AG (IGG) |
| Classification | Autoantibodies, Anti-soluble Liver Antigen (sla), Autoimmune Hepatitis |
| Applicant | EUROIMMUN US 1100 THE AMERICAN ROAD Morris Plains, NJ 07950 |
| Contact | Kathryn Kohl |
| Correspondent | Kathryn Kohl EUROIMMUN US 1100 THE AMERICAN ROAD Morris Plains, NJ 07950 |
| Product Code | NIY |
| Subsequent Product Code | DBM |
| Subsequent Product Code | NBS |
| Subsequent Product Code | NRI |
| Subsequent Product Code | NUM |
| CFR Regulation Number | 866.5660 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2011-11-21 |
| Decision Date | 2013-04-12 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04049016124894 | K113439 | 000 |
| 04049016124887 | K113439 | 000 |