The following data is part of a premarket notification filed by Euroimmun Us Inc with the FDA for Euroimmun Anti-pla2r Elisa (igg).
| Device ID | K132195 |
| 510k Number | K132195 |
| Device Name: | EUROIMMUN ANTI-PLA2R ELISA (IGG) |
| Classification | Anti-phospholipase A2 Receptor |
| Applicant | EUROIMMUN US INC 1100 THE AMERICAN ROAD Morris Plains, NJ 07950 |
| Contact | Michael Locke |
| Correspondent | Michael Locke EUROIMMUN US INC 1100 THE AMERICAN ROAD Morris Plains, NJ 07950 |
| Product Code | PGV |
| CFR Regulation Number | 866.5780 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-07-15 |
| Decision Date | 2014-06-27 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04049016102748 | K132195 | 000 |