FDA 510(k)
Substantially Equivalent
🇺🇸 United States
Xpert Hemorrhagic Fever
K Number: K253653
·
Decision Feb 20, 2026
Classifications
0
FEI Numbers
0
Registration Numbers
0
Same Product Code
0
Applicant Total
50
Review Days
92
Basic Information
- Device Name
- Xpert Hemorrhagic Fever
- K Number
- K253653
- Clearance Type
- Traditional
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Cepheid
- Date Received
- November 20, 2025
- Decision Date
- February 20, 2026
- Advisory Committee
- Unknown
- Review Advisory Committee
- MI
- Third Party
- N
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