FDA 510(k)
Substantially Equivalent
🇺🇸 United States
Xpert C. difficile/Epi
K Number: K243730
·
Decision Feb 28, 2025
Classifications
0
FEI Numbers
0
Registration Numbers
0
Same Product Code
0
Applicant Total
10
Review Days
87
Basic Information
- Device Name
- Xpert C. difficile/Epi
- K Number
- K243730
- Clearance Type
- Traditional
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Cepheid®
- Date Received
- December 3, 2024
- Decision Date
- February 28, 2025
- Advisory Committee
- Unknown
- Review Advisory Committee
- MI
- Third Party
- N
Other Clearances by Cepheid®
| K Number | Device Name | ||
|---|---|---|---|
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| K250995 | Xpert Xpress CoV-2/Flu/RSV plus | May 1, 2025 | Substantially Equivalent |
| K242109 | Xpert® Xpress CoV-2 plus (XPRS-COV2-10) | Jan 15, 2025 | Substantially Equivalent |
| K243625 | Xpert MRSA/SA SSTI | Dec 18, 2024 | Substantially Equivalent |
| K243405 | Xpert vanA | Nov 21, 2024 | Substantially Equivalent |
| K243070 | Xpert® SA Nasal Complete | Oct 25, 2024 | Substantially Equivalent |
| K230440 | Xpert® Xpress CoV-2 plus | Oct 13, 2023 | Substantially Equivalent |
| K231481 | Xpert Xpress CoV-2/Flu/RSV plus | Aug 17, 2023 | Substantially Equivalent |
| K223046 | Xpert® FII & FV | Feb 15, 2023 | Substantially Equivalent |