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FDA 510(k)

Nova Allegro UACR Assay, Nova Allegro Analyzer

K-Number: K252206 · 2026-01-09

ApplicantNova Biomedical Corporation
Decision Date2026-01-09
Product CodeCGX
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

Nova Allegro UACR Assay, Nova Allegro Analyzer is a medical device manufactured by Nova Biomedical Corporation. It received FDA 510(k) clearance on 2026-01-09 under approval number K252206. The device is classified under product code CGX. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Nova Allegro UACR Assay, Nova Allegro Analyzer?

Nova Allegro UACR Assay, Nova Allegro Analyzer is a medical device that received FDA 510(k) clearance on 2026-01-09. It is manufactured by Nova Biomedical Corporation. The 510(k) number is K252206.

When was Nova Allegro UACR Assay, Nova Allegro Analyzer approved by the FDA?

Nova Allegro UACR Assay, Nova Allegro Analyzer received FDA 510(k) clearance on 2026-01-09, under approval number K252206.

What company makes Nova Allegro UACR Assay, Nova Allegro Analyzer?

Nova Allegro UACR Assay, Nova Allegro Analyzer is manufactured by Nova Biomedical Corporation.

What is the FDA product code for Nova Allegro UACR Assay, Nova Allegro Analyzer?

The FDA product code for Nova Allegro UACR Assay, Nova Allegro Analyzer is CGX.

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Related Devices (Code: CGX)

K161494Atellica CH Creatinine_2 (Crea_2), Atellica CH Chemistry Calibrator (CHEM CAL)Siemens Healthcare Diagnostics, Inc. K210452Creatinine2Abbott Ireland Diagnostics Division K242685Atellica® CH Creatinine_3 (Crea3)Siemens Healthcare Diagnostics, Inc. K221813Nova Allegro UACR Assay, Nova Allegro AnalyzerNova Biomedical Corporation K251058Tru Kidney Health Test Panel; Tru AnalyzerTruvian Health

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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