The following data is part of a premarket notification filed by Cepheid with the FDA for Xpert Carba-r.
| Device ID | K160901 |
| 510k Number | K160901 |
| Device Name: | Xpert Carba-R |
| Classification | System, Nucleic Acid Amplification Test, Dna, Antimicrobial Resistance Marker, Direct Specimen |
| Applicant | CEPHEID 904 CARIBBEAN DRIVE Sunnyvale, CA 94089 -1189 |
| Contact | Scott A. Campbell |
| Correspondent | Jim Kelly CEPHEID 904 CARIBBEAN DRIVE Sunnyvale, CA 94089 -1189 |
| Product Code | POC |
| CFR Regulation Number | 866.1640 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-04-01 |
| Decision Date | 2016-06-29 |
| Summary: | summary |