The following data is part of a premarket notification filed by Biomerieux, Inc. with the FDA for Nuclisens Easyq Mrsa; Nuclisens Easyq Analyzer; Nuclisens Easyq Incubator (110 Volt); Nuclisens Director V.2.6.
| Device ID | K102740 |
| 510k Number | K102740 |
| Device Name: | NUCLISENS EASYQ MRSA; NUCLISENS EASYQ ANALYZER; NUCLISENS EASYQ INCUBATOR (110 VOLT); NUCLISENS DIRECTOR V.2.6 |
| Classification | System, Nucleic Acid Amplification Test, Dna, Methicillin Resistant Staphylococcus Aureus, Direct Specimen |
| Applicant | BIOMERIEUX, INC. 100 RODOLPHE ST Durham, NC 27712 |
| Contact | Jocelyn Jennings |
| Correspondent | Jocelyn Jennings BIOMERIEUX, INC. 100 RODOLPHE ST Durham, NC 27712 |
| Product Code | NQX |
| CFR Regulation Number | 866.1640 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2010-09-22 |
| Decision Date | 2011-05-20 |
| Summary: | summary |