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 |