The following data is part of a De Novo classification by Euroimmun Us with the FDA for Euroimmun Anti-pla2r Ifa.
| DeNovo ID | DEN140002 |
| Device Name: | EUROIMMUN ANTI-PLA2R IFA |
| Classification | Anti-phospholipase A2 Receptor |
| Applicant | EUROIMMUN US 1100 The American Road Morris Plains, NJ 07950 |
| Contact | Michael Locke |
| Product Code | PGV |
| CFR Regulation Number | 866.5780 [🔎] |
| Decision | Granted (DENG) |
| 510(k) Premarket Notification | K132379 |
| Review Advisory Board | Immunology |
| Classification Advisory | Microbiology |
| Type | Post-NSE |
| Date Received | 2014-03-28 |
| Decision Date | 2014-05-29 |
| FDA Review | Decision Summary |
| Reclassification Order: | Reclassification Order |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04049016095804 | DEN140002 | 000 |
| 04049016095798 | DEN140002 | 000 |
| 04049016095781 | DEN140002 | 000 |
| 04049016095774 | DEN140002 | 000 |
| 04049016138501 | DEN140002 | 000 |