The following data is part of a premarket notification filed by Biomerieux, Inc. with the FDA for Nuclisens Easyq Enterovirus System.
| Device ID | K063261 |
| 510k Number | K063261 |
| Device Name: | NUCLISENS EASYQ ENTEROVIRUS SYSTEM |
| Classification | Assay, Enterovirus Nucleic Acid |
| Applicant | BIOMERIEUX, INC. 100 RODOLPHE ST Durham, NC 27712 |
| Contact | Sandra Perreand |
| Correspondent | Sandra Perreand BIOMERIEUX, INC. 100 RODOLPHE ST Durham, NC 27712 |
| Product Code | OAI |
| CFR Regulation Number | 866.3225 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2006-10-30 |
| Decision Date | 2008-06-23 |
| Summary: | summary |