The following data is part of a premarket notification filed by Cepheid with the FDA for Xpert Carba-r.
| Device ID | K173263 |
| 510k Number | K173263 |
| 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 |
| Contact | Yi-ping Lin |
| Correspondent | Jim Kelly Cepheid 904 Caribbean Drive Sunnyvale, CA 94089 |
| Product Code | POC |
| Subsequent Product Code | OOI |
| Subsequent Product Code | PMY |
| CFR Regulation Number | 866.1640 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-10-11 |
| Decision Date | 2018-01-09 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 07332940001032 | K173263 | 000 |
| 07332940007720 | K173263 | 000 |
| 07332940007713 | K173263 | 000 |