The following data is part of a premarket notification filed by Biomerieux, Inc. with the FDA for Nuclisens Easyq Enterovirus V1.1., Nuclisens Easyq Director 2.6, Nuclisens Easyq Analyzer, Nuclisens Minimag.
| Device ID | K093383 |
| 510k Number | K093383 |
| Device Name: | NUCLISENS EASYQ ENTEROVIRUS V1.1., NUCLISENS EASYQ DIRECTOR 2.6, NUCLISENS EASYQ ANALYZER, NUCLISENS MINIMAG |
| Classification | Real Time Nucleic Acid Amplification System |
| Applicant | BIOMERIEUX, INC. 100 RODOLPHE ST Durham, NC 27712 |
| Contact | Maria Oyaski |
| Correspondent | Maria Oyaski BIOMERIEUX, INC. 100 RODOLPHE ST Durham, NC 27712 |
| Product Code | OOI |
| CFR Regulation Number | 862.2570 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2009-10-30 |
| Decision Date | 2010-07-06 |
| Summary: | summary |