The following data is part of a premarket notification filed by Euroimmun Us with the FDA for Euroimmun Anti-lkm-1 Elisa(lgg).
| Device ID | K112223 |
| 510k Number | K112223 |
| Device Name: | EUROIMMUN ANTI-LKM-1 ELISA(LGG) |
| Classification | Autoantibodies, Lkm-1 (liver/kidney Microsome, Type 1) |
| 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 | NBS |
| CFR Regulation Number | 866.5660 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2011-08-02 |
| Decision Date | 2012-09-11 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04049016026808 | K112223 | 000 |