FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
XPERT FLU, GENEXPERT DX SYSTEMS, GENEXPERT INFINITY SYSTEM, GENEXPERT SYSTEM SOFTWARE VERISIONS 2.1 AND 4.0
K Number: K103766
·
Decision Apr 21, 2011
Classifications
1
FEI Numbers
3
Registration Numbers
3
Same Product Code
9
Applicant Total
50
Review Days
119
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Basic Information
- Device Name
- XPERT FLU, GENEXPERT DX SYSTEMS, GENEXPERT INFINITY SYSTEM, GENEXPERT SYSTEM SOFTWARE VERISIONS 2.1 AND 4.0
- K Number
- K103766
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 866.3332
- Medical Specialty
- Microbiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Cepheid
- Date Received
- December 23, 2010
- Decision Date
- April 21, 2011
- Product Code
- OQW
- Advisory Committee
- Microbiology
- Review Advisory Committee
- MI
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| OQW | 2009 H1n1 Influenza Virus (Swine Origin), Nucleic Acid Or Antigen, Detection And Identification | FDA class 2 | Microbiology |
Similar 510(k) Clearances
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Other Clearances by Cepheid
| K Number | Device Name | ||
|---|---|---|---|
| K253653 | Xpert Hemorrhagic Fever | Feb 20, 2026 | Substantially Equivalent |
| K251721 | Xpert GI Panel | Jan 16, 2026 | Substantially Equivalent |
| K250218 | Xpert® FII & FV | Feb 21, 2025 | Substantially Equivalent |
| K242071 | Xpert Xpress CoV-2/Flu/RSV plus | Jan 10, 2025 | Substantially Equivalent |
| DEN240016 | Xpert HCV; GeneXpert Xpress System | Jun 27, 2024 | Unknown |
| K231381 | Xpert Xpress MVP; GeneXpert Xpress System | Oct 19, 2023 | Substantially Equivalent |
| K222638 | Xpert® Xpress GBS, GeneXpert® Dx System, GeneXpert® Infinity Systems | Sep 27, 2023 | Substantially Equivalent |
| K221160 | Xpert Xpress MVP, GeneXpert Dx System, GeneXpert Infinity System | Jun 7, 2022 | Substantially Equivalent |
| K203429 | Xpert GBS LB XC, GeneXpert Dx System, GeneXpert Infinity System | May 9, 2022 | Substantially Equivalent |
| K212213 | Xpert Xpress MVP, GeneXpert Dx System, GeneXpert Infinity System | Feb 9, 2022 | Substantially Equivalent |