The following data is part of a premarket notification filed by Euroimmun Us with the FDA for Euroimmun Anti-ena Pool Elisa (igg).
| Device ID | K112996 |
| 510k Number | K112996 |
| Device Name: | EUROIMMUN ANTI-ENA POOL ELISA (IGG) |
| Classification | Extractable Antinuclear Antibody, Antigen And Control |
| 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 | LLL |
| CFR Regulation Number | 866.5100 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2011-10-07 |
| Decision Date | 2013-04-09 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04049016086017 | K112996 | 000 |