Xpert Hemorrhagic Fever— 510(k) K261362
Substantially EquivalentCepheid
FDA 510(k) clearance K261362 for Xpert Hemorrhagic Fever, Substantially Equivalent on 2026-08-07. Applicant: Cepheid. Device class: 2.
Clearance details
- Applicant
- Cepheid
- Product code
- Code QVR
- Device class
- Class 2
- Regulation
- 21 CFR 866.4000
- Advisory panel
- Immunology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Dual Track
- Location
- Sunnyvale, CA, US
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