The following data is part of a premarket notification filed by Cepheid with the FDA for Xpert Mrsa Nxg.
| Device ID | K162444 |
| 510k Number | K162444 |
| Device Name: | Xpert MRSA NxG |
| Classification | System, Nucleic Acid Amplification Test, Dna, Methicillin Resistant Staphylococcus Aureus, Direct Specimen |
| Applicant | CEPHEID 904 CARIBBEAN DRIVE Sunnyvale, CA 94089 |
| Contact | Scott A. Campbell |
| Correspondent | Jim Kelly CEPHEID 904 CARIBBEAN DRIVE Sunnyvale, CA 94089 |
| Product Code | NQX |
| CFR Regulation Number | 866.1640 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-08-31 |
| Decision Date | 2016-11-23 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 07332940001728 | K162444 | 000 |
| 07332940001711 | K162444 | 000 |