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FDA 510(k)

Nova Max Creat eGFR Monitoring System

K-Number: K251281 · 2026-01-21

ApplicantNova Biomedical Corporation
Decision Date2026-01-21
Product CodeSHB
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

Nova Max Creat eGFR Monitoring System is the device name listed in this FDA 510(k) record. The listed applicant is Nova Biomedical Corporation. It received FDA 510(k) clearance on 2026-01-21 under 510(k) number K251281. The device is classified under product code SHB. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Nova Max Creat eGFR Monitoring System?

Nova Max Creat eGFR Monitoring System is a medical device that received FDA 510(k) clearance on 2026-01-21. The listed applicant is Nova Biomedical Corporation. The 510(k) number is K251281.

When did Nova Max Creat eGFR Monitoring System receive FDA 510(k) clearance?

Nova Max Creat eGFR Monitoring System received FDA 510(k) clearance on 2026-01-21, under 510(k) number K251281.

Who is the listed applicant for Nova Max Creat eGFR Monitoring System?

The FDA 510(k) record lists Nova Biomedical Corporation as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Nova Max Creat eGFR Monitoring System?

The FDA product code for Nova Max Creat eGFR Monitoring System is SHB.

Other records listing Nova Biomedical Corporation as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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