The following data is part of a premarket notification filed by Cepheid with the FDA for Xpert C. Difficle/epi Assay.
| Device ID | K110203 |
| 510k Number | K110203 |
| Device Name: | XPERT C. DIFFICLE/EPI ASSAY |
| Classification | C. Difficile Nucleic Acid Amplification Test Assay |
| Applicant | CEPHEID 904 CARIBBEAN DRIVE Sunnyvale, CA 94089 -1189 |
| Contact | Russel K Enns |
| Correspondent | Russel K Enns CEPHEID 904 CARIBBEAN DRIVE Sunnyvale, CA 94089 -1189 |
| Product Code | OMN |
| CFR Regulation Number | 866.2660 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2011-01-24 |
| Decision Date | 2011-04-07 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 07332940000042 | K110203 | 000 |
| 07332940000028 | K110203 | 000 |