The following data is part of a premarket notification filed by Cepheid with the FDA for Xpert C. Difficile.
| Device ID | K091109 |
| 510k Number | K091109 |
| Device Name: | XPERT C. DIFFICILE |
| Classification | Reagents, Clostridium Difficile Toxin |
| 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 | LLH |
| CFR Regulation Number | 866.2660 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2009-04-16 |
| Decision Date | 2009-07-09 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 07332940000059 | K091109 | 000 |
| 07332940000035 | K091109 | 000 |