The following data is part of a premarket notification filed by Euroimmun Us Inc with the FDA for Euroimmun Anti-dsdna-ncx Elisa (igg).
| Device ID | K083381 |
| 510k Number | K083381 |
| Device Name: | EUROIMMUN ANTI-DSDNA-NCX ELISA (IGG) |
| Classification | Anti-dna Antibody (enzyme-labeled), Antigen, Control |
| Applicant | EUROIMMUN US INC 95 WASHINGTON ST Morristown, NJ 07960 |
| Contact | Kathryn Kohl |
| Correspondent | Kathryn Kohl EUROIMMUN US INC 95 WASHINGTON ST Morristown, NJ 07960 |
| Product Code | LRM |
| CFR Regulation Number | 866.5100 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2008-11-14 |
| Decision Date | 2009-04-15 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04049016026884 | K083381 | 000 |