Source document or public record
FDA 510(k) K251281 — Nova Max Creat eGFR Monitoring System
FDA 510(k) index record K251281. Device: Nova Max Creat eGFR Monitoring System. Applicant as listed: Nova Biomedical Corporation. Decision date: 2026-01-21.
Source
"device_name": "Nova Max Creat eGFR Monitoring System"
This entry describes what the document covers; the document itself is the authority. Listing it is not agreement with its conclusions.
Review and references
Automated FDA record verification
2026-10-20
2026-10-20
professional use
FDA 510(k) public index record K251281.
Device name: Nova Max Creat eGFR Monitoring System. Applicant as listed: Nova Biomedical Corporation.
Decision date: 2026-01-21. Decision wording: Substantially Equivalent.
Product code: SHB. Regulation: 21 CFR 862.1225. Medical specialty: Clinical Chemistry.
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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