The following data is part of a premarket notification filed by Euroimmun Us, Inc. with the FDA for Euroimmun Anti-west Nile Virus Elisa (igm).
| Device ID | K153308 |
| 510k Number | K153308 |
| Device Name: | EUROIMMUN Anti-West Nile Virus ELISA (IgM) |
| Classification | Elisa, Antibody, West Nile Virus |
| 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 | NOP |
| CFR Regulation Number | 866.3940 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-11-17 |
| Decision Date | 2016-08-12 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04049016028185 | K153308 | 000 |