The following data is part of a premarket notification filed by Euroimmun Us with the FDA for Euroimmun Anti-nrnp/sm Elisa (igg).
| Device ID | K123261 |
| 510k Number | K123261 |
| Device Name: | EUROIMMUN ANTI-NRNP/SM ELISA (IGG) |
| Classification | Anti-rnp 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 | 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 | 2012-10-18 |
| Decision Date | 2013-06-12 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04049016027232 | K123261 | 000 |
| 04049016027225 | K123261 | 000 |
| 04049016027065 | K123261 | 000 |
| 04049016027058 | K123261 | 000 |
| 04049016027041 | K123261 | 000 |
| 04049016027034 | K123261 | 000 |
| 04049016027027 | K123261 | 000 |
| 04049016027010 | K123261 | 000 |