The following data is part of a premarket notification filed by Euroimmun Us with the FDA for Ana Screen Elisa (igg).
| Device ID | K131185 |
| 510k Number | K131185 |
| Device Name: | ANA SCREEN ELISA (IGG) |
| Classification | Antinuclear Antibody (enzyme-labeled), Antigen, Controls |
| 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 | LJM |
| CFR Regulation Number | 866.5100 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-04-26 |
| Decision Date | 2013-07-15 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04049016026976 | K131185 | 000 |