FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
IntelliSep Test (CV-ICG-048)
K Number: K250513
·
Decision Mar 21, 2025
Classifications
1
FEI Numbers
4
Registration Numbers
4
Same Product Code
2
Applicant Total
3
Review Days
28
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Basic Information
- Device Name
- IntelliSep Test (CV-ICG-048)
- K Number
- K250513
- Device Class
- FDA class 2
- Clearance Type
- Special
- Regulation Number
- 866.3215
- Medical Specialty
- Microbiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Cytovale, Inc.
- Date Received
- February 21, 2025
- Decision Date
- March 21, 2025
- Product Code
- QUT
- 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 |
|---|---|---|---|
| QUT | Deformability Cytometry For Sepsis Risk Assessment | FDA class 2 | Microbiology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (QUT), ordered by most recent decision date.
IntelliSep Test
FDA 510(k)
FDA Class 2
·Microbiology
IntelliSep test
FDA 510(k)
FDA Class 2
·Microbiology