The following data is part of a premarket notification filed by Cepheid with the FDA for Xpert Ct/ng.
| Device ID | K173840 |
| 510k Number | K173840 |
| Device Name: | Xpert CT/NG |
| Classification | Dna-reagents, Neisseria |
| Applicant | Cepheid 904 Caribbean Drive Sunnyvale, CA 94089 |
| Contact | Yi-ping Lin |
| Correspondent | Jim Kelly Cepheid 904 Caribbean Drive Sunnyvale, CA 94089 |
| Product Code | LSL |
| Subsequent Product Code | LIO |
| Subsequent Product Code | MKZ |
| Subsequent Product Code | OOI |
| CFR Regulation Number | 866.3390 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-12-18 |
| Decision Date | 2018-03-16 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 07332940002954 | K173840 | 000 |
| 07332940002558 | K173840 | 000 |