Source document or public record
FDA 510(k) K250513 — IntelliSep Test (CV-ICG-048)
FDA 510(k) index record K250513. Device: IntelliSep Test (CV-ICG-048). Applicant as listed: Cytovale, Inc.. Decision date: 2025-03-21.
Source
"device_name": "IntelliSep Test (CV-ICG-048)"
This entry describes what the document covers; the document itself is the authority. Listing it is not agreement with its conclusions.
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Automated FDA record verification
2026-10-20
2026-10-20
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FDA 510(k) public index record K250513.
Device name: IntelliSep Test (CV-ICG-048). Applicant as listed: Cytovale, Inc..
Decision date: 2025-03-21. Decision wording: Substantially Equivalent.
Product code: QUT. Regulation: 21 CFR 866.3215. Medical specialty: Microbiology.
This page reproduces regulator index metadata. The applicant field identifies the submitter and is not a manufacturer identity check. Consult the original FDA record for the decision and associated documents; this index does not verify current commercial availability or clinical performance.
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