IntelliSep Test (CV-ICG-048)— 510(k) K250513
Substantially EquivalentCytovale, Inc.
FDA 510(k) clearance K250513 for IntelliSep Test (CV-ICG-048), Substantially Equivalent on 2025-03-21. Applicant: Cytovale, Inc.. Device class: 2.
Clearance details
- Applicant
- Cytovale, Inc.
- Product code
- Code QUT
- Device class
- Class 2
- Regulation
- 21 CFR 866.3215
- Advisory panel
- Microbiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Location
- South San Francisco, CA, US
Recent devices under product code QUT
view allData sourced from openFDA. This site is unofficial and independent of the FDA.