Xpert C. difficile/Epi — Cepheid® (510(k) K243730)
Xpert C. difficile/Epi — Cepheid® (510(k) K243730) is one of 9,000 device clearances in the DeviceClear dataset. Key details — Device name: Xpert C. difficile/Epi; Applicant: Cepheid®; Clearance track: 510(k).
| Device name | Xpert C. difficile/Epi |
|---|---|
| Applicant | Cepheid® |
| Clearance track | 510(k) |
| Submission number | K243730 |
| Decision | Substantially Equivalent |
| Decision date | 2025-02-28 |
| Date received | 2024-12-03 |
| Product code | OZN |
| Device class | 2 |
| Medical specialty | Microbiology |
| Applicant location | CA, US |
| Source | openFDA device |
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