The following data is part of a premarket notification filed by Euroimmun Us with the FDA for Euroimmun Euroline Ena Profile 9ag (igg).
| Device ID | K140224 |
| 510k Number | K140224 |
| Device Name: | EUROIMMUN EUROLINE ENA PROFILE 9AG (IGG) |
| Classification | Anti-rnp Antibody, Antigen And Control |
| Applicant | EUROIMMUN US 1100 THE AMERICAN ROAD Morris Plains, NJ 07950 |
| Contact | Michael Locke |
| Correspondent | Michael Locke EUROIMMUN US 1100 THE AMERICAN ROAD Morris Plains, NJ 07950 |
| Product Code | LKO |
| Subsequent Product Code | LJM |
| Subsequent Product Code | LKP |
| Subsequent Product Code | LLL |
| Subsequent Product Code | MQA |
| CFR Regulation Number | 866.5100 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-01-29 |
| Decision Date | 2014-12-09 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04049016124917 | K140224 | 000 |
| 04049016124900 | K140224 | 000 |
| 04049016084785 | K140224 | 000 |
| 04049016083139 | K140224 | 000 |