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 |